FULL_TIME

FEED

OTHER

Reporting to: Vice President, Corporate Affairs Location: Durham, NC (US-based); frequent international travel, including Latin America Classification: Full-Time Exempt Key strengths Strategic program design and risk-based prioritization: Builds systems that scale across sites and countries, and puts audit and surveillance effort where the risk is highest. Founded in 2017 by leading scientists in the gene editing and biotechnology fields, Pairwise holds licenses from Harvard and Massachusetts General Hospital to base editing and high-fidelity enzymes in addition to our own proprietary, company-developed suite of novel tools.

Pairwise Plant Service, Inc.

Associate Director, Product Protection & Stewardship

equestftpin

UNKNOWN

Demonstrated success leading, coaching, or developing others in oncology or a related therapeutic area, gained through formal people leadership or through significant team, project, mentoring, or peer-leadership responsibilities. As a Director, you will build, lead, coach, develop, and manage a high-performing team of MSLs and contribute to the creation and execution of plans linked to GSK's Medical Strategic Objectives, priorities, and Integrated Scientific Communication Plan.

YEAR

GSK plc

Director, Medical Science Liaisons-Oncology

linkup_via_bold

As a recognized subject matter expert, the Executive Director collaborates extensively with Clinical Development, Regulatory Affairs, Medical Affairs, Biostatistics, Epidemiology, Quality, Commercial, Legal, Alliance Management, and Global Patient Safety Operations to influence critical business decisions that impact patient safety, regulatory strategy, and product development. This includes oversight of Brand Safety Leads/Medical Safety Physicians while ensuring scientifically robust safety surveillance, signal evaluation, regulatory compliance, and benefit risk management across all pulmonary portfolio, devices, biologics, combination products, and innovative development programs.

United Therapeutics Corp

Executive Director, Global Safety Strategy & Benefit Risk Management

ADAPTED_NOW

Develops and oversees robust corrective and preventive actions (CAPAs), remediation plans, and audit finding responses to prevent recurrence for both local and global site related commitments; verifies effectiveness through metrics and periodic reviews. Ensures timely availability of site quality performance data, including metrics for quarterly management reviews, to identify emerging regulatory trends and monitor performance against agreed targets for driving improvements and achieving quality objectives.

Fujifilm

Director, Quality Systems & Compliance

Fujifilm-icims

This is a product leadership role with end-to-end accountability across product strategy, the digital customer experience, e-commerce, and roadmap, spanning the full consumer journey from discovery and purchase through testing, results delivery, and ongoing engagement. Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes.

Labcorp

Executive Director, Digital Product Strategy

ea_via_bold

Executive Director, Product Strategy

This is a product leadership role with end-to-end accountability across product strategy, the digital customer experience, e-commerce, and roadmap, spanning the full consumer journey from discovery and purchase through testing, results delivery, and ongoing engagement. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients.

Labcorp Holdings Inc

The Director of Real Estate Global Asset Management leads the global front-end strategy, highest-and-best-use analysis, site selection and disposition, Real Estate due diligence, entitlement, development and master planning support for Cisco's major owned-real estate assets and large campuses. The role will lead through both direct team leadership and enterprise influence, coordinating across Real Estate Strategy, Global Business Partners, Finance and Accounting, Real Estate Transactions, Legal, WPR PMO, Design & Construction, Operations, Government Affairs and external consultants.

Cisco Systems Inc

Director, Global Owned Real Estate Asset Management

We are seeking an Associate Director of Biologics Analytical Development to provide scientific leadership and strategic direction for analytical sciences across a growing biologics development portfolio. This position will play a key role in establishing analytical strategies, advancing late-stage analytical development, and ensuring robust, phase-appropriate analytical methods and control strategies throughout clinical development and toward commercialization.

Actalent Inc

Associate Director, Biologics Analytical Development

It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a strategic leader, the Manager establishes governance frameworks, develops team capabilities, and partners with business and technology stakeholders to ensure master data processes effectively support organizational objectives, regulatory requirements, and digital transformation goals.

Siemens Healthineers

Material Master / Pricing Administrator - Director

Led by an established executive team and backed by world-class life science investors, each day Beeline Medicines is determined to bring the scientific rigor and operational excellence to get to what matters for patients – realizing a world where people with immune-mediated diseases can live life fully. Lead formulation development activities for small molecule drug candidates across all clinical phases, including excipient screening, compatibility studies, formulation optimization, and selection of final drug product composition for clinical and commercial manufacturing.

Beeline Medicines

Director, CMC Product Development - Small Molecule

sourcestack_via_bold

The QISG team brings together Engineering, Safety, Quality, Material Procurement, QA/QC, Right-of-Way Acquisition, Scheduling, Environmental Planning, Permitting, Title and Land Management expertise that ensure outstanding results for our clients. What You'll Bring: Minimum of 15 years’ experience in the electric utility industry performing engineering related duties and/or management for high voltage electrical projects.

Quanta Infrastructure Solutions Group, LLC

Director, Engineering - Transmission Line

[AW]-iCims

As a member of the site Quality Leadership Team, the Director partners cross-functionally with Manufacturing m QA, MSAT, AS&T, and Regulatory to support clinical and commercial manufacturing while advancing quality culture and operational excellence. The Director, Quality Control provides strategic and operational leadership for all Quality Control (QC) activities supporting drug substance (DS) and dug product (DP) manufacturing at the site.

Cellectis

Director, Quality Control

LabCorp

Our pipeline includes two clinical-stage compounds: SCY-770, a novel, highly selective direct AMPK activator in development for autosomal dominant polycystic kidney disease (ADPKD), and SCY-247, a second-generation triterpenoid antifungal candidate currently in clinical stages of development for the treatment and prevention of invasive fungal infections. Perform batch disposition activities for manufactured clinical products, including review and approval of master batch records (MBRs), executed batch records (EBRs), batch review checklists, and Certificates of Analysis (CoAs); coordinate CoA issuance, as applicable, and document batch release authorization in accordance with established procedures and delegated QA authority.

Scynexis Inc

Associate Director, Quality Assurance CMC

Builds awareness and establishes credibility globally of Veranex's capacity and capabilitiesProficiently utilizes digital toolsets and CRM to continuously update prospecting targets and opportunity funnel, ensuring their territory is being met and data is reliably useful to other functions within the organizationProspects and networks using both traditional methods and modern digital toolsets and data to generate leads and identify prospective new clientsEngages prospective clients and coordinates with Veranex subject matter experts and specialists to issue and refine proposals and close sales. As a provider of integrated, end-to-end product and commercialization services, we enhance client value and accelerate our growth by exploring prospective clients' needs broadly and seeking opportunities to provide additional services where possible.

Veranex

Senior Director, Business Development

As the world's only end-to-end professional services firm focused on MedTech, we take clients' Vision to Velocity through our comprehensive service portfolio, with expertise in human centered design and product development, preclinical and clinical research, regulatory affairs, and market access and reimbursement consulting. As a provider of integrated, end-to-end product and commercialization services, we enhance client value and accelerate our growth by exploring prospective clients' needs broadly and seeking opportunities to provide additional services where possible.

Veranex Inc

Ensure your team is the primary systems business partner to functional business leaders across Finance, Supply Chain, Commercial Operations, Medical, Quality, Clinical, Regulatory Affairs and Corporate Functions. * Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Asahi Kasei

Executive Director, IT Business Systems

You will shape studies that demonstrate the clinical, operational, and population-level impact of our products and programs, with the direct responsibilities including: writing protocols, building analysis plans, reviewing data line-by-line, and representing Verily's scientific perspective in discussions with health systems, academic investigators, payers, and pharmaceutical partners. Demonstrated experience personally designing and leading observational studies, registries, or pragmatic clinical trials, including authoring protocols and analysis plans, with a strong knowledge and application of epidemiological methods, biostatistics, and real-world data sources (claims, EHR, patient-reported outcomes).

Director Of Regulatory Affairs Jobs in Morrisville, NC

Associate Director, Product Protection & Stewardship Pairwise Plant Service, Inc.

Director, Medical Science Liaisons-Oncology GSK plc

Executive Director, Global Safety Strategy & Benefit Risk Management United Therapeutics Corp

Director, Quality Systems & Compliance Fujifilm

Executive Director, Digital Product Strategy Labcorp

Executive Director, Product Strategy Labcorp

Executive Director, Product Strategy Labcorp Holdings Inc

Director, Global Owned Real Estate Asset Management Cisco Systems Inc

Associate Director, Biologics Analytical Development Actalent Inc

Material Master / Pricing Administrator - Director Siemens Healthineers

Director, CMC Product Development - Small Molecule Beeline Medicines

Director, Engineering - Transmission Line Quanta Infrastructure Solutions Group, LLC

Director, Quality Control Cellectis

Executive Director, Digital Product Strategy LabCorp

Executive Director, Product Strategy LabCorp

Associate Director, Quality Assurance CMC Scynexis Inc

Senior Director, Business Development Veranex

Senior Director, Business Development Veranex Inc

Executive Director, IT Business Systems Asahi Kasei

Director, Physician Researcher - Evidence Generation & Registries Verily Life Sciences LLC

Similar Job Searches

See More Jobs

Stand out to leading employers.