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ASSOCIATE DIRECTOR, REGULATORY AFFAIRS

Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....

CompanyJohnson And Johnson
AddressSomerville, NJ
CategoryInformation Technology
Job typeFull-Time
Date Posted 2 months ago See detail

Associate Director, Regulatory Affairs

Johnson And Johnson

Somerville, NJ

Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with FDA and Health Canada to find the best development strategies for novel therapies in the areas where no other precedents exist....

2 months ago seen See more...

Director, Regulatory Affairs

Biospace

Waltham, MA

Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings. As a member of program teams, provide global regulatory guidance regarding requirements for clinical development a...

2 months ago seen See more...

Director, Clinical Regulatory Affairs

Cymabay Therapeutics

Newark, CA

Work with Vice President to devise regulatory strategies to ensure rapid and timely approval of products. Develop global regulatory plans to facilitate the progress of programs in all phases of development. Identify risk mitigatio...

4 weeks ago seen See more...

Senior Director, Global Medical Affairs Strategy - Solid Tumors

Genmab A/S

Princeton, NJ

Develop and execute the overall Medical Affairs Strategy for designated product in NSCLC therapeutic area. Serve on Compound Development Team as Global Medical Affairs representative; Co-Lead Global Commercialization Team. Serve a...

4 weeks ago seen See more...

Head/ Sr Director of Global Regulatory Affairs

Predicine, Inc

Hayward, CA

Responsible for setting strategy and leading the Predicine Global Regulatory Affairs organization. Organize and oversee the preparation, review, and submission of regulatory documents to regulatory authorities for In vitro diagnos...

4 weeks ago seen See more...

Senior Director, Corporate Legal Affairs (Hybrid)

A Precision Therapy Company

Cambridge, MA

Handle SEC and Nasdaq reporting and compliance, including drafting 10-K, 10-Q, 8-K, S-3, S-8, annual meeting, and Section 16 filings. Partner with cross-functional teams to review press releases, scripts, medical meeting materials...

4 weeks ago seen See more...

Senior Director - Analytical Regulatory Science

Biospace

California, United States

Drives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle. Guides project teams on preparation of analytical filing conten...

4 weeks ago seen See more...

Senior Manager, Regulatory Affairs - Proliant Health & Biologicals

Lauridsen Group, Inc.

Ankeny, IA

Professional conduct with high attention to detail. Strong verbal and written communication skills. Ability to work collaboratively and coordinate with team members. Competence in multitasking and organizational methods. Self-star...

4 weeks ago seen See more...

Director, Precision Medicine and Digital Health - Global Regulatory Affairs

Takeda Pharmaceuticals

Boise, ID

You will also establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests, and Digital tools to ensure goals/objectives are met. + Und...

4 weeks ago seen See more...

Director, Digital Health Regulatory Affairs

Mcra

West Virginia, United States

Develop and execute regulatory services for client companies, including however not limited to:. Regulatory Submissions (510(k), IDE, PMA, De Novos, BLA, & IND). Regulatory Strategy, Analysis & Development. Design, Review & Implem...

4 weeks ago seen See more...

Senior Associate of Regulatory Affairs, CMC

Meitheal Pharmaceuticals Inc

Chicago, IL

Other duties may be assigned. Serves as the primary regulatory interface with global US FDA manufacturing partners , and internal teams to ensure the business needs for the assigned products are met by anticipating, identifying,...

4 weeks 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...

a month ago seen See more...

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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month 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...

a month ago seen See more...

Director, Global Regulatory Affairs (GRL)

Biospace

Basking Ridge, NJ

Manages, directs, and drives the strategy for all Regulatory activities associated with the registration and support of new and approved drug products. Seeks and incorporate regional and functional RA strategy into a global strate...

2 months ago seen See more...

Senior Director, Strategic Lead US Medical Affairs Gastroenterology

Johnson & Johnson

United, PA

Lead the Gastroenterology team, and the GI Integrated Evidence Team Leader, in developing a scientifically, strategically, and commercially sound strategy of evidence generation to support all Gastroenterology assets. Identify, p...

2 months ago seen See more...

Senior Associate Regulatory Affairs

Amgen

Washington, DC

Execute the international regulatory strategy and regulatory plans.. Prepare supportive documentation for regulatory deliverables.. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments).. Suppo...

2 months ago seen See more...

Senior Associate Regulatory Affairs

Biospace

Washington, DC

Execute the international regulatory strategy and regulatory plans. Prepare supportive documentation for regulatory deliverables. Support regulatory product compliance (e.g. RIM, PMCs, ESC levels, and agency commitments). Support...

2 months ago seen See more...

Senior Counsel. Global Regulatory Affairs

Visa

New York, NY

$201,500 - $262,000 a year

10+ years of relevant work experience with a Bachelors degree and J.D. Admitted to practice law in the United States and in good standing Strong academic credentials Excellent verbal and written communication skills Strong prefer...

2 months ago seen See more...

Senior Manager, Regulatory Affairs

Apellis Pharmaceuticals

Remote

$132K - $167K a year

Manage, review and organize documents intended for regulatory submissions. Act as a liaison with project teams to accomplish specific regulatory deliverables (eg agency meeting briefing materials, orphan designation applications,...

2 months ago seen See more...

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