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SENIOR MANAGER/ASSOCIATE DIRECTOR OF REGULATORY AFFAIRS

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

CompanyTempus
AddressChicago, IL
CategoryInformation Technology
Job typeOther
Date Posted 2 months ago See detail

Senior Manager/Associate Director of Regulatory Affairs

Tempus

Chicago, IL

Developing and leading global regulatory strategies to support business objectives. Leading submissions and correspondence with global regulatory authorities, including 510(k),PMA, De Novo authorizations, IDE, MDR CE marking, UKCA...

2 months ago seen See more...

Director, Medical Affairs (Conferences and Advocacy)

Kyverna Therapeutics

Emeryville, CA

Responsible for planning and logistical support for major conferences, Clinical and Medical team meetings, advisory boards, and other key HCP meetings. With the cross-functional team, responsible for short- and long-range strategi...

2 months ago seen See more...

Director Regulatory Affairs *Remote*

Providence

Beaverton, OR

Be responsible for managing and developing a team tasked with performing regulatory consulting and regulatory product lifecycle support for all Providence Health Plan and Providence Health Assurance business activity and strategic...

2 months ago seen See more...

FSM Director, Faculty Affairs

Northwestern University

Chicago, IL

Partner with internal and external stakeholders within Feinberg and across its clinical affiliate partners to align strategic priorities related to Academic Affairs. Serve as the first point of contact for the academic affairs act...

2 months ago seen See more...

Director, Regulatory Affairs Strategy, Hematology

Biospace

New York, NY

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

2 months ago seen See more...

Director, Regulatory Affairs Strategy, Hematology

Biospace

Basking Ridge, NJ

Provide interpretation of regulatory authorities feedback, policies and guidelines. Lead the development of regulatory strategic plans either directly in conjunction with project teams or through your reports. Own the preparation...

2 months ago seen See more...

Director of Special Projects-Academic Affairs

Bunker Hill Community College

Boston, MA

Participate in grant proposal meetings for new initiatives. Conduct research for proposals, including outreach to faculty and staff. Support completion of grant proposals in collaboration with Grants Office and BHCC Foundation. Co...

2 months 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...

2 months 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...

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Director Regulatory Affairs

Nikang Therapeutics Inc

Wilmington, DE

Integrate knowledge of global regulations to provide regulatory advice to multidisciplinary teams to support clinical and nonclinical development, including preparation and maintenance of IND and CTA filings. Lead multidisciplinar...

2 months ago seen See more...

Associate Director, Graduate Affairs Communications Specialist & CRM Administrator

Seton Hall University

Orange, NJ

The incumbent will assist with the general coordination of all graduate enrollment and recruitment efforts by providing critical strategic leadership where technology, data, reporting, and digital communications are concerned. M...

2 months 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...

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Associate Director, Global Medical Affairs Phase 4 Research in HIV Treatment

Biospace

California, United States

Lead and support GMA-led Phase 4 Research studies in HIV Treatment, specifically for B/F/TAF data generation priorities related to the IRA submission, and as articulated through Gilead strategy documents [BVY indication strategic...

2 months 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...

2 months ago seen See more...

Director, Regulatory Affairs - Pharmaceuticals

Stryker

Mahwah, NJ

Serves as member of the extended business unit leadership team. Able to effectively communicate, interact, and navigate issues at leadership level. Creates long term regulatory strategy for drug products, provides input on combina...

2 months 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...

2 months ago seen See more...

Director, Regulatory Affairs - Advertising, Promotion and Regulatory Compliance

Ferring Pharmaceuticals

Parsippany, NJ

Manage Regulatory Affairs, Advertising & Promotion and Compliance GroupManage the US RA Ad Promo, submission operations, labeling and compliance group staff, including objective setting and career development activities and motiva...

2 months ago seen See more...

Associate Director, Clinical Scientist- Gastroenterology Therapeutic Area – Medical Affairs

Johnson & Johnson

United, PA

...

2 months ago seen See more...

Associate Director, Medical Affairs - Program Management

Merck

Rahway, NJ

Support the SRO Lead in the execution of extensive, global initiatives, ensuring the program objectives and timelines are consistently met.. Facilitate the creation and approval of all project deliverables, including maintaining d...

2 months 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...

2 months ago seen See more...

Director of Inclusive Faculty Affairs

Dartmouth College

Hanover, NH

5-7 years of experience in project planning, management and community building. Demonstrated experience with developing, implementing and assessing diversity, equity, and inclusion initiatives in partnership with faculty and staff...

2 months ago seen See more...

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