816

Senior Regulatory Affairs Specialist Jobs Near San Francisco, CA

Salary Range

$225K

$225K

Average Salary: $225,000
Senior Director, Regulatory Affairs

Provide strategic regulatory contributions in the development and ongoing review of integrated project development plans. Lead regulatory activities for assigned investigational hepatitis B programs...

Posted 4d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs

Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner...

Posted 5d ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Vice President, Regulatory Affairs

Pro-actively drive communications with all regulatory bodies to obtain all necessary IND’s and other regulatory pre-approvals for clinical research, as well as BLA/MAA approvals for Company products o...

Posted 2d ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Senior Manager, Regulatory Affairs

Provide strategic input and function as the regulatory lead on project teams, and will provide guidance/advice to the project leader and team on regulatory matters...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Director of Regulatory Affairs

Ensure early diagnostic regulatory input in early stages and during clinical development to Development Team for the LUNAR product.

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Associate Director, Regulatory Affairs
$100K - $150K

Develop regulatory strategies for our lead program in the areas of anemia and inflammation in collaboration with Regulatory senior management and through analysis of guidance and assessment of drugs w...

Posted 1w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Senior Director of Regulatory Affairs

Maintain regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedence...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, CMC Regulatory Affairs

Provide strategic input and function as the regulatory lead on project teams, and will provide guidance/advice to the project leader and team on regulatory matters...

Posted 1w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Senior Regulatory Affairs Specialist

Support product development teams on regulatory issues, including review of documentation.

Posted 4w ago

  •   Less than 5 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs & Clinical Operations

Develop and implement regulatory strategies and policies in collaboration with other departments and functions including but not limited to Quality, Legal, Manufacturing, Operations, and R&D...

Posted 1w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Manager/senior Manager, Regulatory Affairs
$100K - $150K

Advise, develop and execute on regulatory strategy to support product launch and/or commercial delivery. Maintain regulatory filings and communications with regulatory agencies and/or external partner...

Posted 2w ago

  •   5 - 7 years exp.  •  Manufacturing & Automotive

Director, Regulatory Affairs
$200K - $250K

Provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line with corpo...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Manager, Regulatory Affairs
$100K - $150K

Represents Regulatory Affairs function in external activities benefiting business interests including trade associations, professional organizations, and standards development organizations...

Posted 3w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Sr. Director, Regulatory Affairs - Modis
$200K - $250K

Responsible for regulatory leading the compilation of all clinical/nonclinical regulatory submissions for MT1621. Directs the creation of high quality, compliant submissions within defined timelines...

Posted 2w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Director, Regulatory Affairs CMC

Lead the Regulatory Affairs CMC group to prepare and submit high-quality regulatory CMC submissions in collaboration with Technical Operations, Quality, and Regulatory Affairs colleagues to meet compa...

Posted 3w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Technical Regulatory Affairs Director

Supports investigational new drug applications (IND), ex-US clinical trial applications (CTA), new drug applications (NDA), and related correspondence from the US Food and Drug Administration...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Senior Director/Vice President, Regulatory Affairs
$250K - $500K

Provide regulatory strategic and tactical leadership for drug development projects, including health authority interactions, regulatory submissions and other regulatory requirements in line...

Posted 2w ago

  •   15+ years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs IVD
$200K - $250K

Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and tactical plans for submissions to FDA and other regulatory agencies, as needed...

Posted 3w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Director, Regulatory Affairs (Device)
$150K - $200K
Intarcia TherapeuticsHayward, CA 94541 and 1 other location

Provide critical review of documents for devices and drug-device combination products (e.g., design control, technical file, dossier, registration, pharmaceutical packaging and related scientific/tech...

Posted 3w ago

  •   5 - 7 years exp.  •  Pharmaceuticals & Biotech

Director / Sr. Director, Global Regulatory Affairs

Lead multidisciplinary efforts to produce regulatory documents including Investigator Brochures, Annual Reports and DSURs, Orphan Drug Applications, and Background Documents for Regulatory Authority m...

Posted 2w ago

  •   8 - 10 years exp.  •  Pharmaceuticals & Biotech

Counsel - Regulatory and Labor Affairs
$150K - $200K

The ideal candidate will work closely with Spin’s legal, and cross-functional teams - including policy, community, government, HR and operations - advising on regulatory impacts of international, fede...

Posted 3w ago

  •   5 - 7 years exp.  •  Consumer Technology

Manager, Regulatory Affairs and Market Policy
$150K - $200K

The senior analyst/manager would help the team address the regulatory issues of most concern to Calpine in California including resource adequacy, integrated resource planning, renewables procurement...

Posted 3w ago

  •   5 - 7 years exp.  •  Energy & Utilities

Director, Regulatory Affairs
$200K - $250K

Lead the Filing team through NDA planning and submission, including pre-NDA meetings and managing post-submission information requests.Communicate and interact within department, division (Inc.), exte...

Posted 4w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech

Senior Product Regulatory Counsel
$200K - $250K

Provide thoughtful advice and counsel on both clear and ambiguous areas of the law to cross-functional stakeholders, including design, research, engineering, data, operations, and marketing teams, as...

Posted 2w ago

  •   8 - 10 years exp.  •  Finance & Insurance

Director Regulatory Affairs

Plans, manages, and creates Clinical Trial Applications, Market Applications and amendments; ensures that submission documents and correspondence are of the highest quality in terms of content, organi...

Posted 4w ago

  •   11 - 15 years exp.  •  Pharmaceuticals & Biotech