Regulatory Affair Lead jobs

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DIRECTOR, REGULATORY AFFAIRS STRATEGY - GENETIC MEDICINE

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...

CompanyBiospace
AddressNew York, NY
CategoryInformation Technology
Job typeFull time
Date Posted 2 weeks ago See detail

Director, Regulatory Affairs Strategy - Genetic Medicine

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...

Associate Director, Regulatory Affairs - Inflammation & Immunology

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...

Associate Director, Regulatory Affairs - Inflammation & Immunology

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...

Director, Regulatory Affairs Strategy - Genetic Medicine

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...

Director, Regulatory Affairs Strategy - Genetic Medicine

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...

Associate Director, Regulatory Affairs Advertising and Promotion

Biospace

California, United States

Provides commercial regulatory support to high-volume brands or therapeutic area and projects without managerial oversight, as appropriate. Reviews and approves promotional materials.. Serves as PRC Chair for one or more high-volu...

Associate Director, Regulatory Affairs - Inflammation & Immunology

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...

Associate Director, Regulatory Affairs Strategy - Genetic Medicine

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...

Director, Global Regulatory Lead (Oncology)

Biospace

Boston, MA

Interfaces with the LRST and AST to lead and support cross-functional company objectives.Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for developmen...

Regulatory Affairs Manager - Now Hiring

Abbott Laboratories

Texas, United States

$95000 - $190000 per year

Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...

Sr Regulatory Affairs Specialist

Johnson & Johnson

Irvine, CA

...

Manager, Global Regulatory Affairs CMC Submissions Management

Takeda Pharmaceutical

Bronx, NY

$138,500 - $186,000 per year

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC Submissions Management in...

Senior Director, Global Regulatory Strategy, Therapeutic Area Lead

Biogen

Olin, NC

15+ years of experience in drug development and regulatory affairs in the biotechnology or pharmaceutical industry. 5 years of leadership experience in a regulatory affairs management role. In depth and relevant Global regulatory...

Associate Director - Regulatory Affairs - AD Promo

Biospace

Princeton, NJ

Provide strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape. Assess risk and advise on mitigation strategies to meet overall business need, while maintai...

Director Regulatory Affairs

Paysafe

Jacksonville, FL

Bachelor's degree; advanced degree preferred. Minimum of 8 years of experience in Regulatory Affairs, compliance, or legal roles within the financial services industry, with a focus on payments, fintech, or e-commerce. Strong unde...

Director Regulatory Affairs - Submission Management - West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Responsible to manage Product Submission Team and dossier timelines. Accountable to Global Regulatory Lead and Global Regulatory Affairs, with matrixed accountability to Project Management. Regularly reports to management on progr...

Director, Regulatory Affairs, Oncology - Job ID: 1311

Ascendis Pharma

Palo Alto, CA

Medical insurance. Vision insurance. Dental insurance. 401(k). Paid maternity leave. Paid paternity leave. Commuter benefits. Disability insurance. Life Insurance (Basic, Voluntary & AD&D)....

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...

Certification and Licensing Coordinator, Regulatory Affairs, Full time, Days

Pih Health

Los Angeles, CA

Effective written/oral communication, and presentation skills. Problem-solving skills. Strong knowledge of performance improvement tools and techniques. Proficient computer literacy. California RN License. Bachelors Degree in hea...

Specialist - Regulatory Affairs

Biospace

Plainsboro, NJ

Therapeutic Area:. Assist Manager/Director in review of labeling for marketed products and new products as assigned. Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guideli...

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...

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...

Manager, Regulatory Affairs

Invenergy

Chicago, IL

Monitor, coordinate and lead advocacy efforts at state economic and environmental regulatory bodies (public utility commissions, public service commissions, utility boards, state procurement entities, state EPA or siting authoriti...

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...

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...

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...

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...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

Vice President Regulatory Affairs, Obesity

Biospace

Thousand Oaks, CA

Develops the vision of the Regulatory Therapeutic Area for Obesity and Obesity Related Conditions (ORCs) and drives its execution, ensuring the globalization of strategy and process. Represents the Regulatory Affairs Therapeutic A...