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SENIOR DIRECTOR, REGULATORY AFFAIRS CMC , INNOVATIVE MEDICINE (HYBRID)

Influence the strategy and assess the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration.. Ident...

CompanyTeva Pharmaceuticals
AddressWest Chester, PA
CategoryInformation Technology
Date Posted 2 weeks ago See detail

Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid)

Teva Pharmaceuticals

West Chester, PA

Influence the strategy and assess the quality of documents for regulatory submissions to major market health authorities as well as coordinate with global regulatory colleagues to prepare dossiers for global registration.. Ident...

2 weeks ago seen See more...

Senior Director, Regulatory Affairs II

Teva Pharmaceuticals

West Chester, PA

Manage resources to support submission activities for responsible sites and oversees the coordination and delivery of major submissions to directly support the companies growth strategy. Build relationships with RA staff/authorin...

2 weeks ago seen See more...

Senior Director, Regulatory Affairs

Alx Oncology Inc.

South San Francisco, CA

Providing dynamic regulatory leadership and guidance to project teams and working collaboratively with cross-functional team members, external contractors, vendors and consultants to identify optimum and effective regulatory strat...

a month ago seen See more...

Senior Manager Regional Regulatory Affairs

Biospace

King Of Prussia, PA

You will be the primary CSL representative to regional health authorities for assigned products.. Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with resp...

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Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity

Biospace

Washington, DC

To lead GRTs within Amgens GRAAS organization. To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes...

3 weeks ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Raynham, MA

...

3 days ago seen See more...

Senior Regulatory Affairs Program Lead

Johnson & Johnson

Irvine, CA

...

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Regulatory Affairs Senior Program Manager

Biospace

San Francisco, CA

6+ years of Regulatory Affairs experience in the biopharmaceutical industry or equivalent Pref Knowledge of regulatory requirements and early to mid-clinical stage experience with US regulatory submissions for therapeutic products...

3 days ago seen See more...

Director, Regulatory Affairs

Biospace

San Diego, CA

Accountable for the development and implementation of the regulatory strategy for AnaptysBios pipeline programs. Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively neg...

4 days ago seen See more...

Senior Advisor/Director, Global Regulatory Affairs – CMC

Biospace

Indianapolis, IN

Deep technical knowledge of synthetic molecule CMC drug development science(s). Knowledge of global CMC regulatory requirements and guidelines for conducting clinical trials and obtaining global product registrations. Development...

4 weeks ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Pix11

New York, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs/products of high complexity are established and maintained, and plans & directs the seamless e...

3 days ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Takeda Pharmaceutical

Brooklyn, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless...

4 days ago seen See more...

Senior Director, Global Regulatory Project Management, GI ²

Takeda Pharmaceutical

Bronx, NY

Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure Global Regulatory Project plans for programs / products of high complexity are established and maintained, and plans & directs the seamless...

4 days ago seen See more...

Senior Director, Commercial Regulatory Affairs

Mitsubishi Tanabe Pharma

Jersey City, NJ

Actively leads, develops, and implements strategic and tactical support for commercial, post approval regulatory activities for successful and compliant promotion and scientific engagement activities and review submission packages...

2 months ago seen See more...

Associate Director, Regulatory Affairs

Biospace

San Rafael, CA

Lead the development, integration, execution and maintenance of the global nonclinical and clinical regulatory strategy for the Global Regulatory Plan (GRP) throughout the product lifecycle. Ensure strategic alignment with the Cli...

a week ago seen See more...

Senior Director, Medical & Professional Affairs

Warby Parker Inc.

New York, NY

$235,000 per year

Senior Director, Medical & Professional Affairs needed by Warby Parker Inc. in New York, NY [and various unanticipated locations throughout the U.S.; may work from home] to lead a team of optometrists, some independent...

6 days ago seen See more...

Senior Regulatory Affairs Specialist

Iconma, Llc

Saint Paul, MN

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...

2 weeks ago seen See more...

Senior Regulatory Affairs Specialist

Collabera

Saint Paul, MN

Perform assigned regulatory activities including submissions/responses to country authorities. Daily Responsibilities - suppliers should use: Plan and prepare documents for EU MDR Technical File original submiss...

2 weeks ago seen See more...

Senior Regulatory Affairs Specialist

Axelon

Saint Paul, MN

This position will be working with multiple business units to develop, update, and improve regulatory affair processes. Assist the strategy implementation and operations for Regulatory Affairs activities, including directing devel...

2 weeks ago seen See more...

Director, Regulatory Affairs Specialty, HIV

Gsk

Olin, NC

Ensuring the regulatory strategy that will deliver the needs of the local region(s), taking in to account the needs of other regions globally. Implementation of the regional strategy(ies) in support of the project globally. Lead r...

2 weeks ago seen See more...

Director, Regulatory & Quality Affairs

Mdc Associates

Beverly, MA

Direct and coordinate MDCs Regulatory Affairs activities. Collaborate with other MDC departments including Clinical Affairs and Quality Systems to ensure continuity of service across client projects. Support business development...

2 weeks ago seen See more...

Director, Regulatory Affairs Companion Diagnostics

Biospace

Basking Ridge, NJ

CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing. At the time of implementation of a CDx study/...

2 weeks ago seen See more...

Associate Director, Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

United States

Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management. P...

2 weeks ago seen See more...

Executive Director, Regulatory Affairs

Biospace

San Diego, CA

Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization. Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek...

2 weeks ago seen See more...

Regulatory Affairs Senior Consultant

Medenvoy Global Bv

Remote

From $100,000 a year

Reviewing and processing of serious incidents related of medical devices of customers. Supervision of field safety corrective actions performed by clients. Communication with competent authorities and clients. Addressing post mark...

2 weeks ago seen See more...

Director, CMC Regulatory Affairs Biologics

Biospace

California, United States

Lead CMC regulatory strategy for a single or multiple products. Lead the execution and influence the development of global CMC regulatory strategies, including risk mitigation strategies to ensure right first-time approvals of pro...

2 weeks ago seen See more...

Senior Director, Field Medical Lead, Medical Affairs

Arrowhead Pharmaceuticals

Pasadena, CA

$260,000 - $300,000 a year

Develop, maintain, and execute external engagement strategic Field Medical plan. Drive the identification, profiling, and segmentation of opinion leaders (OLs). Identify, hire, and train top candidates to build a highly effective...

2 weeks ago seen See more...

Senior Director, U.S. Medical Affairs (USMA) HIV Prevention Strategy - Lenacapavir

Gilead Sciences

Remote

$249,645 - $323,070 a year

Leads US HIV Prevention Strategy and medical tactical planning specific to lenacapavir for PrEP. Leadership of a remote team of individuals developing and executing on Prevention Strategy Seeks out and develops educational opportu...

2 weeks ago seen See more...

Executive Director, Advertising & Promotions Regulatory Affairs

Ortho Dermatologics

Charleston, WV

$280,000 - $320,000 a year

Manages the Regulatory Promotional reviews for prescription drugs who represent Regulatory Affairs on the promotional review committee for marketed products. This position may require reviewing promotional materials if the company...

2 weeks ago seen See more...

Senior Manager, Regulatory Affairs Biocides - Remote

Steris

Alpharetta, GA

Home Based / Remote opportunity. 20% Domestic Travel Required. 10% International Travel Required. Identify and keep current with the various US EPA, EU BPR and other international country submission/registration/approval and compl...

2 weeks ago seen See more...

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