NewEHS Manager JobotEHS ManagerSmithfield, NC$110,000–$130,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. Rather than simply maintaining compliance, the organization is looking for a hands-on EHS leader who enjoys being on the manufacturing floor, engaging employees, identifying opportunities for improvement, and driving a proactive safety culture.
NewManager, Respiratory Therapy - Pediatrics Duke HealthManager, Respiratory Therapy - PediatricsDurham, NCEffectively identifies, processes, and resolves conflict to align and unify team(s), mobilizes team members to progress in parallel together, and effectively focuses team members on organizational and departmental goals. Meet regularly with clinical and operational partners in area(s) of service to assess team outcomes, identify needs, derive solutions, support open and timely communication, and maintain positive business relationships.
NewDialysis Clinical Manager Registered Nurse - RN Fresenius Medical CareDialysis Clinical Manager Registered Nurse - RNRaleigh, NCOther: • Collaborates closely with, providing oversight as needed to, the Clinical Manager/Charge RN acting as nurse manager, the Medical Director, and the physicians regarding the direct patient care responsibilities within the facility to ensure the provision of outstanding quality of patient care, as defined by the FMS quality goals, and compliance with the pertinent company policies and procedures. • Demonstrated leadership competencies and management skills for the position, including excellent communication, customer service, continuous quality improvement, relationship development, results orientation, team building, motivating employees, performance management and decision making.
NewBanking Center Manager II First Horizon BankBanking Center Manager IIDurham, NCHeadquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
NewBanking Center Manager First Horizon BankBanking Center ManagerDurham, NCHeadquartered in Memphis, TN, the banking subsidiary First Horizon Bank operates in 12 states across the southern U.S. The Company and its subsidiaries offer commercial, private banking, consumer, small business, wealth and trust management, retail brokerage, capital markets, fixed income, and mortgage banking services. First Horizon Corporation is a leading regional financial services company, dedicated to helping our clients, communities and associates unlock their full potential with capital and counsel.
NewCase Manager (RN) Home Health Duke HealthCase Manager (RN) Home HealthDurham, NCDevelop plan of care for aides, assign care to aides based on the skills of the aide, the availability of the aide for patient care continuity, patient preference (when possible), and other considerations as determined by the patient’s care needs. Duke HomeCare and Hospice provides innovative and thoughtful care by using an interdisciplinary team approach to achieve the best possible outcomes for patients, families and the communities for which they serve.
NewCase Manager (RN) Hospice Home Care Duke HealthCase Manager (RN) Hospice Home CareDurham, NCDevelop plan of care for aides, assign care to aides based on the skills of the aide, the availability of the aide for patient care continuity, patient preference (when possible), and other considerations as determined by the patient’s care needs. Pursue your passion for caring with Duke HomeCare & Hospice, which offers hospice, home health, and infusion services across the region, as well as serves as the home forthe Duke Caregiver Support Program.
NewCase Manager Adult Transplant Duke HealthCase Manager Adult TransplantDurham, NCThe largest of the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more. Coordinate services such as Home Health, Durable Medical Equipment (DME), transportation, Substance Abuse Treatment, outpatient follow-up, Skilled Nursing Facility (SNF) placement, and Acute Rehab referrals.
NewSenior Safety Manager HITT ContractingSenior Safety ManagerRaleigh, NCEvery day, our team members do amazing things in pursuit of our shared purpose to build trust with our clients, partners, subcontractors, and teammates. This individual is seen as a subject matter expert within HITT and plays a pivotal role in developing HITT’s corporate safety program and safety culture.
NewNurse Manager-Cardiology Duke HealthNurse Manager-CardiologyMorrisville, NCThe Nurse Manager reports to the Practice Administrator to integrate both overall clinic and nursing priorities into operational workflows, promote quality improvement initiatives, and support provider teams. Serve as a resource and liaison for patients, staff, and providers regarding nursing and operational concerns, escalating as appropriate to Practice Administrator or Ambulatory Operations Director.
NewNurse Manager- Duke Innovative Pain Therapies Duke HealthNurse Manager- Duke Innovative Pain TherapiesRaleigh, NCCultivate exemplary customer service throughout the organization; promote effective communication skills to include, but not limited to problem solving, assertiveness, and support for team members, feedback, active listening and conflict resolution. Promote education for patients, patient families and the community; participate in direct patient care activities as a targeted strategy for role modeling or information gathering.
Project Manager - Healthcare/Commercial Projects - Raleigh Michael Page USAProject Manager - Healthcare/Commercial Projects - RaleighRaleigh, NC$90,000–$135,000 / yearFull timeServe as a strategic problem‑solver who adds value to client projects while supporting preconstruction efforts, including estimating and project planning. The Project Manager will lead large‑scale commercial, retail, and healthcare projects while mentoring and developing project teams.
Project Manager - Commercial/Industrial - Raleigh Michael Page USAProject Manager - Commercial/Industrial - RaleighRaleigh, NC$90,000–$125,000 / yearFull timeServe as a strategic problem‑solver who adds value to client projects while supporting preconstruction efforts, including estimating and project planning. The Project Manager will lead large‑scale commercial, retail, and healthcare projects while mentoring and developing project teams.
Restaurant Assistant Manager Zaxby'sRestaurant Assistant ManagerLouisburg, NCp>To our guests, Zaxbys is more than just a place to eat – it’s a place to have fun, spend time with friends, and enjoy great food. Supervise, provide leadership, and coach team members to perform at their highest level of ability and strive to achieve quarterly goals.
RN Patient Services Manager III - Rex Labor and Delivery UNC HealthRN Patient Services Manager III - Rex Labor and DeliveryRaleigh, NCDuties include ensuring that appropriate care and services are available to patients and families, ensures adequate and appropriate clinic staffing on each shift, supervision of nursing staff, medical support staff and utility aide staff, assistance with annual performance reviews of staff, participation in quality improvement initiatives to address identified patient safety or quality of care issues. This is a critical leadership role responsible for guiding both the clinical and administrative operations of a fast-paced, patient-centered environment dedicated to supporting families during one of life’s most meaningful moments.
RN Patient Services Manager III- Cardiology and Oncology Stepdown Unit UNC HealthRN Patient Services Manager III- Cardiology and Oncology Stepdown UnitChapel Hill, NCDuties include ensuring that appropriate care and services are available to patients and families, ensures adequate and appropriate clinic staffing on each shift, supervision of nursing staff, medical support staff and utility aide staff, assistance with annual performance reviews of staff, participation in quality improvement initiatives to address identified patient safety or quality of care issues. Provides and facilitates an environment conducive to staff continuing education needs, ongoing unit-based educational needs and orientation of staff members.
NewAssistant Community Manager Asset LivingAssistant Community ManagerFuquay Varina, NC$25–$28 / hourin all directions, lift and place objects up to 25 lbs, operate machinery or power tools, operate motor vehicles and/or golf carts, identify and inspect objects, be able to work overtime, weekends, night hours (emergencies) work in small and/or enclosed spaces, traverse flat and non-flat terrain, work in extremely low or high temperatures, work in outdoor environments such as precipitation and wind, be exposed to hazardous chemicals. The employee is occasionally required to ascend/descend ladders, stairs, scaffolding, ramps, step stools, and the like, move self into different positions to accomplish tasks in various environments including tight and confined spaces, work in an overhead position and reach, adjust or move objects of up to 25 lbs.
NewBranch Manager United RentalsBranch ManagerDurham, NCAs Branch Manager with our Fluid Solutions Division you will have the opportunity to hire and motivate an amazing team in various roles, from sales and service to maintenance and drivers. The actual pay rate offered to candidates varies depending upon a wide range of factors including specific position, location, education, training, experience, skills, and ability.
NewRN Patient Services Manager III- Holly Springs 6 Bedtower (Med Surg) UNC HealthRN Patient Services Manager III- Holly Springs 6 Bedtower (Med Surg)Holly Springs, NC$47.90–$68.86 / hourDuties include ensuring that appropriate care and services are available to patients and families, ensures adequate and appropriate clinic staffing on each shift, supervision of nursing staff, medical support staff and utility aide staff, assistance with annual performance reviews of staff, participation in quality improvement initiatives to address identified patient safety or quality of care issues. This unit supports patients with complex medical needs, post-operative recovery, chronic illness management, and transitional levels of care.
NewRN Patient Services Manager III - Orthopedic Department UNC HealthRN Patient Services Manager III - Orthopedic DepartmentSmithfield, NC$47.90–$68.86 / hourDuties include ensuring that appropriate care and services are available to patients and families, ensures adequate and appropriate clinic staffing on each shift, supervision of nursing staff, medical support staff and utility aide staff, assistance with annual performance reviews of staff, participation in quality improvement initiatives to address identified patient safety or quality of care issues. Provides and facilitates an environment conducive to staff continuing education needs, ongoing unit-based educational needs and orientation of staff members.
NewRN Patient Services Manager I - Gynecologic Oncology Clinic UNC HealthRN Patient Services Manager I - Gynecologic Oncology ClinicChapel Hill, NC$38.55–$55.43 / hourp>Summary: This position is responsible for: ensuring that appropriate enjoy and services are available to patients and families, ensuring adequate and appropriate clinical staffing on each shift, supervision of nursing staff, HUC staff and utility aide staff, assistance with annual performance reviews of staff, participation in quality improvement initiatives to address identified patient safety or quality of care issues, providing and facilitating an environment conducive to staff continuing education needs, on-going unit-based educational needs and orientation of staff members. Quality Improvement- Leads and participated in quality improvement initiatives that focus on identified patient safety or quality of care deficits.
NewCase Manager- PRN M-F Duke HealthCase Manager- PRN M-FDurham, NCThe largest of the four Duke Healthhospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more. Coordinate services such as Home Health, Durable Medical Equipment (DME), transportation, Substance Abuse Treatment, outpatient follow-up, Skilled Nursing Facility (SNF) placement, and Acute Rehab referrals.
NewSenior Manager, Regulatory Affairs (Ad Promo) ICON PLCSenior Manager, Regulatory Affairs (Ad Promo)Raleigh, NCContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices . Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
Regulatory Affairs Manager / Senior Regulatory Affairs Manager - Biologics United Therapeutics CorpRegulatory Affairs Manager / Senior Regulatory Affairs Manager - BiologicsNCProvide regulatory support for assigned products/projects, coordinating cross-functional activities with various UTC product development groups (e.g., nonclinical, clinical, quality, marketing, safety, medical) to support execution of regulatory activities and adherence to established timelines. The Regulatory Affairs Manager, Biologics/Senior Regulatory Affairs Manager, Biologics will lead regulatory activities for assigned existing and new programs, supporting product development from early development through post-approval.
Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) Parexel International CorpSenior Regulatory Affairs Consultant (Program / Client Partnership Manager)NCYou will play a key leadership role in managing midsize to large Regulatory Affairs outsourcing programs, partnering closely with clients and cross-functional teams to drive operational excellence, ensure delivery against regulatory objectives, and support the successful progression of development and commercial programs. Due to continued growth and the ongoing success of our Regulatory Affairs Consulting team, Parexel is seeking an experienced Senior Regulatory Affairs Consultant (Program / Client Partnership Manager) to join our team.
Senior Manager, Regulatory Affairs (Ad Promo) IRESenior Manager, Regulatory Affairs (Ad Promo)Raleigh, North CarolinaContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices. Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
Manager Regulatory Affairs Bioventus IncManager Regulatory AffairsDurham, NCWorks with stakeholders to serve as a point person for regulatory agency interactions, including preparation of briefing packages, including presentations, and strategy for meetings, and response to agency letters pertaining to assigned products. Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, concisely and effectively verbally and in writing.
Sr. Regulatory Affairs Manager Validation & Engineering GroupSr. Regulatory Affairs ManagerNCValidation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.
Regulatory Affairs Project Manager, US Remote Fortrea IncRegulatory Affairs Project Manager, US RemoteDurham, NCRemote$115,000–$130,000 / yearThe Regulatory Affairs Project Manager will be responsible for developing and managing budgets, timelines, and quality guidelines for projects, thereby ensuring that expectations are met while identifying and mitigating risks. University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution.
Senior Manager, Regulatory Strategy ICON PlcSenior Manager, Regulatory StrategyRaleigh, NCContribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning (PDP/RDP/CDP), scientific/agency advice, orphan drugs/pediatric development, medical devices. Demonstrable experience within regulatory affairs, including development of regulatory strategies, document writing, marketing authorization applications, clinical trials, post-licensing activities, and direct regulatory agency interaction.
Manager/Sr. Manager, Regulatory Affairs (Labeling) Grifols SAManager/Sr. Manager, Regulatory Affairs (Labeling)Clayton, NCSummary: Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation. Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements.
US State Regulatory Manager UPL LtdUS State Regulatory ManagerCary, NCDevelop and maintain vital relationships by interacting with state regulatory agencies, trade organizations, grower groups, industry task forces, and trade associations to effectively communicate the Company's regulatory concerns and objectives REQUIRED EDUCATION AND EXPERIENCE: Ideal candidate will possess at least a minimum of a bachelor's degree (ideally within a scientific discipline) with approximately 5 or more years' direct hands-on industry experience in the US State Regulatory matters. Reporting to Region Regulatory Head, North America, the State Regulatory Manager is responsible for new product submissions, product renewals, label amendment changes, state dossier submissions, sales & marketing enablement, and other state regulatory activities, along with professional interaction with the state and/or local regulatory authorities, trade associations, grower groups, customers and industrial partners as required by job function.
NewSenior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSLSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesHolly Springs, NC$154,000–$182,000 / yearThe role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Crop Protection Regulatory Manager, US UPL LtdCrop Protection Regulatory Manager, USNCManage & deliver on regulatory requirements & applications towards new technical and end use product registrations, re-evaluations, label modifications, source changes, data call-ins, import tolerances, and all EPA PRIA and non-PRIA actions to maintain, defend, and expand uses for UPL brand products. About UPLUPL (NSE: UPL & BSE: 512070, LSE: UPLL) is focused on emerging as a premier global provider of total crop solutions designed to secure the world's long-term food supply.
Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSL Behring LLCSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesHolly Springs, NC$154,000–$182,000 / yearThe Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Senior Manager, Regional Regulatory Lead – North America, Seqirus Vaccines CSL PlasmaSenior Manager, Regional Regulatory Lead – North America, Seqirus VaccinesHolly Springs, North Carolinap/>The role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
NewSenior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines SeqirusSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesHolly Springs, NC$154,000–$182,000 / yearThe role contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new and marketed products.
Senior CMC Regulatory Strategy Manager GSK plcSenior CMC Regulatory Strategy ManagerDurham, NC$144,375–$240,625 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.
Information Systems Sr. Manager – Technology Regulatory Compliance Lead AmgenInformation Systems Sr. Manager – Technology Regulatory Compliance LeadHolly Springs, North CarolinaAmgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Information Systems Sr. Manager - Technology Regulatory Compliance Lead Amgen IncInformation Systems Sr. Manager - Technology Regulatory Compliance LeadHolly Springs, NC$147,259–$174,934 / yearThe professional we seek is an individual with these qualifications: Basic Qualifications: • Doctorate degree and 2 years of Information Systems/Technology and/or Engineering experience • Master's degree and 4 years of Information Systems/Technology and/or Engineering experience • Bachelor's degree and 6 years of Information Systems/Technology and/or Engineering experience • Associate's degree and 10 years of Information Systems/Technology and/or Engineering experience • High school diploma / GED and 12 years of Information Systems/Technology and/or Engineering experience. Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including: • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
Regulatory Reporting Manager Deloitte Touche Tohmatsu LtdRegulatory Reporting ManagerNC$82,600–$162,800 / yearManage end to end regulatory reporting activities covering 40 Act and non-40 Act funds in the investment management space (e.g., Form PF, TIC, CPO-PQR, Form 16, Form 13, N-PX, BEA reports), ensuring compliance with applicable regulatory requirements across various regulators such as SEC, CFTC, BEA, NFA, Treasury. We "embed continuous advantage" through domain, industry, technology and transformation skills to perform client business functions that manage risk and deliver value-added outcomes, all while driving predictable long-term revenue, profitability, and growth.
Food Safety Program Manager - Regulatory Support Chewy IncFood Safety Program Manager - Regulatory SupportClayton, NCWhat You'll Need: BS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is; required; Advanced MS in Chemistry, Biology, Food Safety, Food Science, Environmental; Engineering; or related technical field is preferred ; Minimum of 2+ years in Food Safety and Quality Control in a distribution, warehousing, and/or manufacturing setting. The Regional Food Safety Specialist will; be responsible for; partnering with the Site Operations team, Continuous Improvement, Learning, Quality, and Facility teams to manage the deliverables; required; at the FC network.
Sr. Director, Strategic Regulatory Affairs and UDI Teleflex IncSr. Director, Strategic Regulatory Affairs and UDIMorrisville, NC$203,000–$253,000 / yearThe position leads a global organization through a team of managers and functional leaders and serves as a key partner to Regulatory Affairs, Quality, Supply Chain, Manufacturing, Information Technology, Commercial, and Executive Leadership teams to ensure regulatory compliance, support global market access, and enable business growth. The Senior Director, Strategic Regulatory Affairs & UDI provides leadership and oversight for global regulatory operations, regulatory systems, unique device identification (UDI), regulatory data governance, import/export regulatory compliance support, and regional Regulatory Affairs and Quality functions.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyRaleigh, NCDevelopment and implementation of clinical regulatory strategies and tactics,including but not limited to, Modeling Informed Drug Development (MIDD), real- world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets,while considering FDA and other health authority clinical and regulatory requirements. As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director – Clinical Strategy will conduct in depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications.
Director (Senior Director), Regulatory Affairs Shattuck Labs IncDirector (Senior Director), Regulatory AffairsDurham, NCIncluded among the necessary activities are: oversight of regulatory CRO activities, planning and leading: meetings with regulatory authorities, compilation and submission of high-quality INDs, CTAs, BLAs/MAAs, meeting packages, responses to requests for information, amendments, and required elements such as safety reports, annual reports. Lead the preparation of regulatory submissions, ensuring the planning, coordination, preparation, and review of all submissions to global regulatory authorities including INDs, CTAs, BLAs, MAAs, amendments, responses to information requests and questions, safety reports, and annual updates/DSURs for assigned projects.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyRaleigh, NCBrief Team/Department Description: As a part of the Regulatory Affairs team at Azurity, the Regulatory Affairs Director - Clinical Strategy will conduct in-depth analysis of regulatory and clinical information to develop complex strategies supporting potential drug products for development and commercial drug products for expansion of the Azurity portfolio of medications. Principle Responsibilities: • Development and implementation of clinical regulatory strategies and tactics, including but not limited to, Modeling Informed Drug Development (MIDD), real-world data (RWD)/real-world evidence (RWE), and meta-analysis, for pipeline and commercial assets, while considering FDA and other health authority clinical and regulatory requirements.
Senior Director, Advertising and Promotional Compliance Lead - Global Regulatory Affairs Merz North America IncSenior Director, Advertising and Promotional Compliance Lead - Global Regulatory AffairsRaleigh, NCThe individual will oversee or represent regulatory on global and certain regional PRC (Promotional Review Committee) teams, SRC (Scientific Review Committee) teams and must possess a thorough knowledge of regulations for medical affairs activities, advertisement and promotional compliance governing drugs, device, cosmetic, and combination products and the ability to translate regulatory requirements into decision-ready guidance for senior stakeholders. Lead the team within Global Regulatory Affairs that provides strategic regulatory expertise and guidance to global internal leaders and stakeholders regarding the marketing of products including review of advertising, promotional and other related materials to ensure compliance with applicable regulations and guidance documents.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals IncVice President, Global Head of Regulatory AffairsRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - USVice President, Global Head of Regulatory AffairsRaleigh, NCAs an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients.
NewRegulatory Affairs Specialist Zp Group LlcRegulatory Affairs SpecialistNCCoordinate with cross-functional teams including Regulatory Affairs, Quality, Manufacturing, Technical Operations, and CMC subject matter experts to gather and review submission content. Job Summary: Piper Companies is seeking a Regulatory Affairs Specialist I - CMC to support our end client''s Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs team.