Logo
Inspira Talent

Head of Regulatory Affairs

Inspira Talent, San Francisco

Save Job

3 days ago Be among the first 25 applicants

Inspira Talent is currently partnered with a nimble biotech in SF Bay developing novel biologics for autoimmune disease. They recently raised Series B from leading VC firms to drive their lead program into the clinic.

External Description

The Head of Regulatory Affairs leads regulatory strategy and operations across this biotech's development programs. This leadership role ensures compliance with FDA, EMA, and global regulatory standards and provides strategic guidance on non-clinical and clinical development. The position partners cross-functionally with clinical, CMC, nonclinical, and executive teams to drive regulatory submissions and agency interactions.

Key Responsibilities

  • Regulatory Strategy: Lead development and execution of global regulatory strategies, particularly for non-clinical and clinical programs.
  • Submissions: Oversee preparation and submission of INDs, NDAs, BLAs, and MAAs, ensuring accuracy and compliance.
  • Compliance & Intelligence: Monitor evolving regulatory requirements and guide internal teams accordingly.
  • Agency Interactions: Act as primary liaison with regulatory bodies, leading meetings and responses.
  • Risk Management: Identify regulatory risks and advise on mitigation strategies.

Qualifications

  • BSc, M.S., Ph.D in a scientific field.
  • 10+ years in pharma/biotech, with 3+ years immunology/autoimmune experience
  • Deep understanding of preclinical, clinical, and regulatory processes.
  • Strong leadership, communication, and cross-functional collaboration skills.

Seniority level

  • Seniority level

    Director

Employment type

  • Employment type

    Full-time

Job function

  • Job function

    Administrative, Research, and General Business

  • Industries

    Biotechnology Research and Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Inspira Talent by 2x

Get notified about new Head of Regulatory Affairs jobs in San Francisco Bay Area .

Director/Senior Director, Regulatory Affairs Strategy

Vice President / Head of Regulatory Affairs

Director, Regulatory Affairs - Job ID: 1702

San Francisco County, CA $250,000.00-$275,000.00 2 weeks ago

Transparency and Regulatory Affairs Director

Cotati, CA $153,094.00-$169,209.00 3 days ago

Executive Director, Regulatory Affairs CMC

Senior Director, Global Regulatory Affairs

Foster City, CA $270,000.00-$285,000.00 2 weeks ago

San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago

Senior Director, Regulatory Affairs - Job ID: 1668

Director, Regulatory Affairs Global Labeling

San Francisco Bay Area $295,000.00-$326,000.00 2 weeks ago

Director, Global Regulatory Affairs - Neurosciences

Palo Alto, CA $188,800.00-$283,200.00 2 weeks ago

San Francisco, CA $230,000.00-$245,000.00 2 weeks ago

Exec Director, Regulatory Affairs-Combination Products & Devices

Director, Quality Assurance and Regulatory Affairs

San Jose, CA $201,000.00-$251,000.00 2 weeks ago

Regulatory Affairs Director - Oncology Cell & Gene Therapy

South San Francisco, CA $168,664.00-$252,997.00 6 days ago

Associate Vice President of Diagnostics Regulatory Affairs

Commercial Regulatory Affairs Director (Advertising and Promotion)

Alameda, CA $167,500.00-$237,500.00 2 weeks ago

Head of Quality & Compliance, Monarch Platform

Santa Clara, CA $200,000.00-$343,850.00 3 days ago

Director Life Sciences Regulatory Affairs and Labeling

South San Francisco, CA $286,500.00-$374,000.00 3 days ago

San Francisco, CA $265,000.00-$315,000.00 2 months ago

Head of Compliance and Enterprise Risk Management

TA HEAD, GLOBAL HEOR | multiple clinical assets - build team | seeking SD / ED / VP | Renowned Boston Pharma

San Francisco, CA $115,000.00-$130,000.00 5 days ago

San Francisco, CA $115,000.00-$130,000.00 2 months ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr