NewSenior Manager, Asset Management – Financial Reporting, Accounting & Regulatory Policy Fidelity InvestmentsSenior Manager, Asset Management – Financial Reporting, Accounting & Regulatory PolicyGoffstown, NHRemote$89,000–$180,000Please be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. As a Senior Manager of Regulatory and Policy Oversight for Alternatives and Digital Assets in Asset Management’s Treasurers Office, you will be essential in supporting emerging regulatory requirements, accounting and financial reporting policies for Fidelity’s evolving alternative and digital asset products.
NewMaintenance Divisional Manager JobotMaintenance Divisional ManagerNorth Andover, MA$120,000–$140,000 / yearOur client, a growing and multi-site industrial organization, is seeking an experienced Maintenance Divisional Manager to provide strategic leadership and oversight for maintenance operations across multiple facilities. Information 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.
NewTax Manager JobotTax ManagerMethuen, MA$130,000–$150,000 / 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. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
NewCommercial Lines Account Manager (Hybrid) JobotCommercial Lines Account Manager (Hybrid)Manchester, NH$80,000–$110,000 / yearThe Commercial Lines Account Manager is responsible for managing and servicing a portfolio of commercial insurance accounts, acting as a key liaison between clients, producers, carriers, and internal teams. This role is ideal for a Commercial Lines Account Manager who enjoys taking ownership of their book, values collaboration, and wants to grow within a forward-thinking brokerage that is actively investing in its people and future.
NewTax Manager Kforce Inc.Tax ManagerWakefield, MA$120,000–$160,000Summary: Our client is seeking a Tax Manager with 5-10 years of public accounting experience who is interested in participating in a high growth environment and working with a diverse client base. Our firm offers the successful candidate the ability to service all aspects of our clients' business and see client engagements from start to finish, thus becoming a valued advisor to clients.
NewDomestic Tax Manager Kforce Inc.Domestic Tax ManagerChelmsford, TX$135,000–$155,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
Contracts Manager III (MA) GCR Professional ServicesContracts Manager III (MA)Andover, Massachusetts$45–$53 / hourContractorThe Contracts Manager will play a crucial role in managing and overseeing contractual agreements and relationships with clients, suppliers, and other stakeholders in the defense and aerospace industry. Risk Management: Identify and assess potential risks and liabilities associated with contracts and propose appropriate mitigation strategies.
NewQuality Manager JobotQuality ManagerGardner, MA$75,000–$90,000 / yearThe Quality Manager will be responsible for implementing and maintaining our Quality Management Systems, ensuring compliance with ISO 9001, and driving improvements using Six Sigma, Lean Manufacturing, and other quality tools. Information 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.
NewSecurity Manager IN-10.11 CredenceSecurity Manager IN-10.11Hanscom Air Force Base, MAThe AFLCMC/IN mission also enables linkages to the Air Force and Joint/National Intelligence Communities (IC), provides predictive battle space awareness to local force protection activities, and provides local/regional Special Security Office (SSO) support and Joint Worldwide Intelligence Communication Services (JWICS) access. Develop, review, and maintain security documentation, including but not limited to SCIF/SAPF certifications, System Security Plans, Program Protection Plans (PPP), OPSEC plans, risk analyses, CONOPS, DD Form 254s, and other MIL-STD and DoDI-compliant artifacts.
NewProgram Manager SevitaProgram ManagerChichester, NHIn a variety of locations and community-based settings, we offer a range of programs, including vocational and therapy programs, day treatments, and specialized services for infants, children, adolescents, Military Service Members and Veterans. Supervise and manage assigned staff, including performance evaluations and scheduling; resolve employee relations issues as needed; make decisions related to employment Supervise clinical and crisis management and establish on-call duties .
NewProgram Manager, Senior - Secret DCS CorporationProgram Manager, Senior - SecretBedford, MA$90,220–$120,000 / yearThe Air Force Program Execution Office for PEO Digital (AFPEO/HB) has the collective Air Force Materiel Command (AFMC) mission responsibility to manage and execute the modernization, development, testing, production, fielding, and sustainment of the PEO Electronic Systems portfolio, which includes over 130 programs for the United States Air Force (USAF) and foreign allies. Bachelor’s degree in a professional engineering discipline from an ABET-accredited program, and minimum of 12 years of experience in the respective technical/professional discipline, including at least 5 years supporting DoD programs.
NewTest Manager, Journeyman - Secret DCS CorporationTest Manager, Journeyman - SecretBedford, MA$60,467–$100,000 / yearAs part of the International Airborne Battle Management Command and Control Division (AFLCMC/WIW), the selected candidate will provide acquisition, engineering, logistics, cybersecurity, test, or program management support, as applicable to their assigned role, ensuring successful execution of FMS efforts while supporting cost, schedule, performance, and mission objectives for a key international partner. The Air Force Program Executive Office for Intelligence, Surveillance, Reconnaissance and Special Operations (PEO ISR SOF) manages the modernization, development, testing, production, fielding, and sustainment of over 200 programs supporting the United States Air Force and allied partners worldwide.
NewTravel Nurse RN - Nurse Manager - $60 to $63 per hour in Exeter, NH TravelNurseSourceTravel Nurse RN - Nurse Manager - $60 to $63 per hour in Exeter, NHExeter, NH$60–$63Job Summary The RN Unit Manager oversees the daily operations of an assigned nursing unit, ensuring quality resident care, regulatory compliance, and effective staff supervision. This role coordinates care plans, monitors clinical outcomes, and supports nursing staff to maintain a safe and positive resident environment.
NewManager, Alternative Investments Shareholder Reporting Fidelity InvestmentsManager, Alternative Investments Shareholder ReportingMerrimack, NHRemoteInvestment OperationsPlease be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Doing this in the smartest and most effective way is more important than ever as we are in the midst of implementing Fidelity’s new and alternative investment products, new and changing regulations, and a brand new technology platform that will transform the way we work.
NewSenior Manager, Alternative Investments Shareholder Reporting Fidelity InvestmentsSenior Manager, Alternative Investments Shareholder ReportingDerry, NHRemoteInvestment OperationsPlease be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Doing this in the smartest and most effective way is more important than ever as we are in the midst of implementing Fidelity’s new and alternative investment products, new and changing regulations, and a brand new technology platform that will transform the way we work.
NewSr. Manager, Alternative Investments Limited Partnership Shareholder Reporting Fidelity InvestmentsSr. Manager, Alternative Investments Limited Partnership Shareholder ReportingMerrimack, NHRemoteInvestment OperationsPlease be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. Doing this in the smartest and most effective way is more important than ever as we are in the midst of implementing Fidelity’s new and alternative investment products, new and changing regulations, and a brand new technology platform that will transform the way we work.
NewTravel Nurse RN - Nurse Manager in Peterborough, NH TravelNurseSourceTravel Nurse RN - Nurse Manager in Peterborough, NHPeterborough, NHResponsibilities include: Providing direct patient care by assessing, planning, implementing, and evaluating nursing interventions to ensure optimal outcomes. Collaborating with physicians, fellow nurses, and other healthcare professionals to develop and implement individualized patient care plans.
NewDirector, Derivatives and Liquid Alternative Investments Product Manager Fidelity InvestmentsDirector, Derivatives and Liquid Alternative Investments Product ManagerDerry, NHRemote$110,000–$222,000Please be advised that Fidelity’s business is governed by the provisions of the Securities Exchange Act of 1934, the Investment Advisers Act of 1940, the Investment Company Act of 1940, ERISA, numerous state laws governing securities, investment and retirement-related financial activities and the rules and regulations of numerous self-regulatory organizations, including FINRA, among others. These benefits include comprehensive health care coverage and emotional well-being support, market-leading retirement, generous paid time off and parental leave, charitable giving employee match program, and educational assistance including student loan repayment, tuition reimbursement, and learning resources to develop your career.
District Human Resources Manager - Boston PenskeDistrict Human Resources Manager - BostonLondonderry, NHThe District Human Resources Manager is a valued member of the Human Resources and Field Operations teams, reporting directly to the District Manager, with a dotted line to the Area Human Resources Manager who aligns with Field Operations and corporate HR. If you have HR functional experience and skills, e.g., managing associate performance, leading difficult discussions, developing associates, ability to anticipate evolving business, we are interested in hearing from you, including if this experience was gained during time spent in a Penske operational role.
NewPlanning Manager Page GroupPlanning ManagerExeter, NH$120,000–$130,000 / yearFull timeA successful Planning Manager should have: A strong background in procurement and supply chain management within the Technology & Telecoms industry. We are seeking a dedicated Planning Manager to oversee and optimize supply chain operations within the Technology & Telecoms industry.
NewBranch Manager Herc Rentals IncBranch ManagerLondonderry, NHFounded in 1965, Herc Rentals is one of the leading equipment rental suppliers in North America with 2025 total revenues reaching approximately $4.4 billion. Please be advised that the actual salary offered for any position is subject to the company's sole discretion and may be influenced by various factors, including but not limited to the candidate's qualifications, experience, location, and overall fit for the role.
NewProgram Manager, Senior DCS CorporationProgram Manager, SeniorBedford, MA$90,220–$180,000 / yearEPASS support is required to execute the major GNS programs in support of the C2ISR Division, to include AF DCGS Network Infrastructure Transformation (NIT), Extended Tether Program (ETP), and Global Command and Control System – Air Force Infrastructure (GCCS-AF (I)). The C2ISR Division provides worldwide life cycle support across the spectrum of the C2ISR capabilities-based enterprise; including supply, distribution, materiel management, acquisition, system engineering and maintenance, financial planning and budgeting, security, flight test, and contracting functions.
NewProgram Manager, Senior - TS DCS CorporationProgram Manager, Senior - TSBedford, MA$90,220–$180,000 / yearEPASS support is required to execute the major GNS programs in support of the C2ISR Division, to include AF DCGS Network Infrastructure Transformation (NIT), Extended Tether Program (ETP), and Global Command and Control System – Air Force Infrastructure (GCCS-AF (I)). The C2ISR Division provides worldwide life cycle support across the spectrum of the C2ISR capabilities-based enterprise; including supply, distribution, materiel management, acquisition, system engineering and maintenance, financial planning and budgeting, security, flight test, and contracting functions.
Safety Manager - Life Science Projects Michael Page USASafety Manager - Life Science ProjectsAndover, MA$100,000–$130,000 / yearFull timeThis privately held construction management firm focuses exclusively on life science, lab, and clean room environments, supporting pharmaceutical and research clients across greater Boston. The Safety Manager will oversee and implement comprehensive safety programs to ensure compliance with regulations and promote a safe working environment for all construction projects.
Sr. Project Manager - Life Science Construction Michael Page USASr. Project Manager - Life Science ConstructionAndover, MA$145,000–$165,000 / yearFull timeProject Manager - Life Science Construction will oversee and manage construction projects within the life sciences sector, ensuring they are completed on time, within scope, and on budget. This privately held construction management firm specializes exclusively in life science and lab environments, supporting pharmaceutical clients across Eastern Massachusetts.
NewSenior Manager, Digital Assets Operations Fidelity InvestmentsSenior Manager, Digital Assets OperationsDerry, NHRemote$89,000–$180,000From a platform coordination perspective, you will help ensure that the required custodians, wallets, vendor applications, internal platforms, investment universe data, staking data, reference data, and related operating inputs are identified, tracked, and completed by the appropriate system or process owners. This role sits within the Digital Assets team in Global Product Solutions (GPS) and is focused on ensuring the digital asset ecosystem is configured correctly, owned correctly, documented clearly, and operating effectively across FFIO service lines and business partners.
NewCase Manager II Encompass Health Rehabilitation Hospital of PetersburgCase Manager IIManchester, VAJoin Encompass Health, where being a Case Manager goes beyond just a job; it positions you as a vital link between exceptional care and the transformative impact on each patient's journey. Our achievements include being named one of the "World's Most Admired Companies" and receiving the Fortune 100 Best Companies to Work For® Award, among other accolades, which is nothing short of amazing.
Sr. EHS Manager Michael Page USASr. EHS ManagerStratham, NH$138,000–$175,000 / yearFull timeThis senior leadership role oversees all environmental, health, and safety programmes, ensuring full regulatory compliance and continuous improvement across the site. You will drive safety strategy, lead audits and training initiatives, and act as a key advisor to leadership on all EHS matters.
NewSenior Manager, Regulatory Affairs NAM Straumann GroupSenior Manager, Regulatory Affairs NAMAndover, MAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
NewSenior Regulatory Affairs Consultant (Program / Client Partnership Manager) ParexelSenior Regulatory Affairs Consultant (Program / Client Partnership Manager)Concord, NHRemoteYou 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.
Manager, Regulatory Affairs LeMaitreManager, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Senior Manager, Regulatory Affairs NAM Straumann Holding AGSenior Manager, Regulatory Affairs NAMMAThis role leads the planning, preparation, and submission of regulatory filings (e.g., Pre-Submissions, 510(k)s, PMAs, PMA Annual Reports, IDEs, and License Applications) and serves as a key regulatory partner to cross-functional teams. This role collaborates closely with global regulatory counterparts within the Straumann Group (e.g., Medentika, Neodent, Anthogyr, Dental Wings, etc.) and manages/develops regulatory staff and/or leads complex regulatory projects.
Regulatory Affairs Project Manager DEKA Research & DevelopmentRegulatory Affairs Project ManagerManchester, NHFull timeHow you will make a difference as a Regulatory Project Manager: Work in close association with customers and development teams to define and execute regulatory approval and clearance programs, including establishing regulatory requirements and leading the preparation and submission of 510(k)s, PMAs, IDEs, Technical Files, and other international dossiers. Expertise in current FDA processes including the eSTAR submission tool, establishment registration and listing, UDI, product labeling, and post-market reporting including MDR’s and Field Action Reporting.
Manager, Regulatory Affairs LeMaitre Vascular IncManager, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Senior Manager, Regulatory Affairs Getinge ABSenior Manager, Regulatory AffairsNashua, NHRemoteThe Senior Manager, Regulatory Affairs, provides regulatory strategy and execution leadership for U.S., EU, and Rest of World (ROW) market access and compliance to enable safe, compliant market access for a broad Surgical Workflows Infection Control Consumable (SWICC) products portfolio, including a wide range of infection control consumables, while also supporting capital equipment such as sterilizers, washer-disinfectors, ultrasonic equipment, surgical lights, and operating tables. Serve as Regulatory Affairs authority in cross-functional product development teams, ensuring regulatory requirements are embedded in design controls, technical documentation, risk management (ISO 14971), labeling, and verification/validation planning, with accountability for U.S. (FDA), EU MDR, and applicable ROW regulatory decision-making.
Regulatory Affairs Manager II Post Market WerfenRegulatory Affairs Manager II Post MarketBedford, MassachusettsFull timeLead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.
Regulatory Affairs Project Manager - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Project Manager - Vascular (on-site)Westford, MA$99,300–$198,700 / yearCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society).Previous experience with 510k / PMA submissions Experience working with hardware/ software devicesFamiliarity with Predetermined Change Control Plans (PCCPs)Experience with Medical DevicesMust be able to juggle multiple and competing prioritiesExercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsHas a sound knowledge of a variety of alternatives and their impact on the businessApply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. WHAT YOU'LL DO Provide regulatory input to product lifecycle planningMonitor regulatory outcomes of initial product concepts and provide input to senior regulatory managementAssist in the development of multi-country regulatory strategy and update strategy based upon regulatory changesAssist in regulatory due diligence for potential and new acquisitionsUtilize technical regulatory skills to propose strategies on complex issuesMonitor trade association positions for impact on company productsAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
NewSenior Manager, Global Regulatory Affairs CMC EMD GroupSenior Manager, Global Regulatory Affairs CMCNorth Billerica, MA$134,200–$202,200 / yearYour Role: The Senior Manager Regulatory CMC (RCMC) is responsible and accountable for driving all CMC regulatory activities including development, authoring and ownership of the CMC dossier Strategy Document as well as all CMC Dossier types, their content and decision making on content, for assigned submissions worldwide, and serves as the Regulatory Affairs CMC contact point and acts as the liaison with the GHO and R&D functions, being the contact person for all Regulatory CMC topics. Develops, authors and owns the CMC dossier Strategy Document as well as all CMC Dossier types; being accountable for CMC Dossier content and content decision of all CMC Dossier types such as IMPD/IND, BB (incl.
Regulatory Affairs Manager PGI FoodsRegulatory Affairs ManagerLowell, Massachusetts$105,000–$125,000 / yearFull timeThe Regulatory Affairs Manager serves as the company's regulatory expert and trusted business partner, ensuring that products, ingredients, packaging, and labeling comply with all applicable regulatory requirements while supporting the successful launch of new products. If you're a strategic regulatory professional who enjoys partnering across departments, navigating complex food regulations, and driving continuous improvement, this is an opportunity to make a significant impact while advancing your career with a growing company.
Principal Regulatory Affairs Specialist Medtronic PlcPrincipal Regulatory Affairs SpecialistDanvers, MAThis role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation.
Regulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.Regulatory Affairs Associate:$71,449+ YRAyer, MAAbility to sit for extended periods, perform visual inspections of labels/documents, occasional lifting up to 25 lbs., standing/walking/bending as needed. Perform regulatory research, document reviews, label proofreading, version control, and cross-functional coordination to enable compliant product release.
Regulatory Affairs Associate Ajinomoto Cambrooke, Inc.Regulatory Affairs AssociateAyer, MassachusettsFull timeThe employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines. • Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions.
Regulatory Affairs Associate Ajinomoto Health & Nutrition North America, Inc.Regulatory Affairs AssociateAyer, MassachusettsFull timeThe employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines. • Assist with RAM with investigating and resolving discrepancies related to packaging, labeling or documentation, and collaborating with internal teams to implement rapid, compliant solutions.
Director, Regulatory Affairs – Clinical Strategy Azurity Pharmaceuticals - USDirector, Regulatory Affairs – Clinical StrategyWoburn, MADevelopment 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 of Quality Assurance and Regulatory Affairs Biomedical SearchDirector of Quality Assurance and Regulatory AffairsLittleton, MAThe Director will oversee Quality and Regulatory functions across multiple sites, ensuring compliance with FDA, ISO 13485, and other applicable regulations while partnering closely with Operations, Engineering, and Executive Leadership. This individual will play a key role in shaping quality strategy, strengthening the Quality Management System (QMS), leading audits and CAPA activities, and developing a high-performing QA/RA team.
Director, Regulatory Affairs - Clinical Strategy Azurity Pharmaceuticals IncDirector, Regulatory Affairs - Clinical StrategyWoburn, MABrief 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.
Director, Global Labeling - Regulatory Affairs SpringWorks Therapeutics IncDirector, Global Labeling - Regulatory AffairsBillerica, MA$182,100–$273,100 / yearYour Role: The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. About SpringWorks Therapeutics: SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.
Associate Director Regulatory Affairs – Vascular (on-site) AbbottAssociate Director Regulatory Affairs – Vascular (on-site)Westford, MassachusettsMaintains expert working knowledge of laws, regulations and enforcement decisions related to Quality Assurance (QA), manufacturing and Research & Development (R&D) issues that may impact company operations and decision making; communicates such knowledge to all internal stakeholders. As a manager, the function of an Associate Director, Regulatory Affairs is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation.
Vice President, Global Head of Regulatory Affairs Azurity Pharmaceuticals - USVice President, Global Head of Regulatory AffairsWoburn, MAAs 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.