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(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics

10+ years
$ 205,000 - $260,000
10 March 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

(Associate) Director/Senior Director, Regulatory Affairs, Therapeutics

Company: Mammoth Biosciences
Location: Brisbane, CA (On-site, 2-3 days per week)
Employment Type: Full-Time

Opportunity:

Mammoth Biosciences is seeking an (Associate) Director/Sr. Director, Regulatory Affairs, Therapeutics to lead regulatory activities for its CRISPR-based therapeutic programs from concept to market. This role will be responsible for regulatory strategy, interactions, and filings while working closely with external consultants and internal teams. The position will eventually oversee the build-out of the regulatory function within the company and will report to the SVP of Translational Science.

Key Responsibilities:

  • Lead and manage the regulatory strategy for Mammoth's CRISPR pipeline.
  • Establish the regulatory pathway for IND filings in complex programs using gene editing technology.
  • Collaborate with regulatory consultants, advisory board members, and board members to stay updated on US and EU regulatory frameworks.
  • Act as a liaison with regulatory agencies, ensuring compliance with evolving guidelines.
  • Work closely with CMC, nonclinical research, and clinical research teams to maintain compliance with global regulations.
  • Develop and coordinate high-quality regulatory submissions for global clinical trials.

Required Qualifications:

  • Education: Bachelor's degree in Life Sciences (Advanced degree preferred).
  • Experience:
    • Associate Director: Minimum 10+ years in biotechnology/biopharmaceutical industry (Master’s degree with 8+ years or PhD with 6+ years).
    • Senior Director: Minimum 12+ years in biotechnology/biopharmaceutical industry (Master’s degree with 10+ years or PhD with 8+ years).
    • Minimum 7 years in Regulatory Affairs, focusing on drug development.
    • Experience in US and global clinical trial submissions (CBER/OTAT or ex-US equivalent).
    • Proven track record with regulatory agencies.
    • Strong project management skills and regulatory compliance expertise.
    • Experience with gene therapy product regulatory requirements.
    • Ability to work on-site at least 2-3 days per week in the Bay Area.

Preferred Qualifications:

  • Advanced degree in Life Sciences.
  • Creative problem-solving skills and strategic thinking.

Benefits:

  • Company-paid health, vision, and dental benefits.
  • Unlimited vacation and generous sick leave.
  • Company-sponsored meals and snacks.
  • Wellness, caregiver, and ergonomics benefits.
  • 401(k) with company matching.
  • Base Salary Range: $205,000 - $260,000 (actual salary based on experience and internal equity).

About Mammoth Biosciences:

Mammoth Biosciences is a biotechnology company leveraging proprietary ultracompact CRISPR systems to develop curative therapies and decentralized precision diagnostics. Founded by Jennifer Doudna and a team of leading scientists, Mammoth is pioneering in vivo gene editing in hard-to-reach tissues using nuclease applications, base editing, gene writing, and epigenetic editing. The company has partnerships with leading pharmaceutical and biotech companies and is committed to transforming patient lives through innovative CRISPR technologies.