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Director/Senior Director, Regulatory Affairs, Therapeutics

6-10 years
$205,000 - $260,000
10 Dec. 13, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Director/Sr. Director, Regulatory Affairs, Therapeutics – Mammoth Biosciences
Location: Bay Area, CA (Hybrid – Onsite 2-3 times per week)

About Mammoth Biosciences:
Mammoth Biosciences is a pioneering biotechnology company specializing in ultracompact CRISPR systems for gene editing and decentralized precision diagnostics. Founded by Nobel laureate Jennifer Doudna, Mammoth aims to develop long-term curative therapies and next-generation gene editing applications, including base editing, gene writing, and epigenetic editing. Mammoth’s technology is at the forefront of revolutionizing CRISPR therapies, with a mission to transform the lives of patients through innovative CRISPR solutions.

Position Overview:
Mammoth is seeking a Director/Sr. Director, Regulatory Affairs, Therapeutics to lead the regulatory activities for its growing CRISPR-based therapeutic programs. This role is crucial in coordinating regulatory strategy, interactions, and filings, while also overseeing external consultants in the short term. Over time, this position will be responsible for building the regulatory function within the company. This leadership role will report directly to the SVP of Translational Science and play a critical part in the successful development of Mammoth’s therapeutic candidates.

Key Responsibilities:

  • Lead and define the strategic regulatory direction for Mammoth’s pipeline, particularly in gene editing therapies.
  • Establish regulatory pathways to IND filing, navigating complex programs utilizing novel gene editing technology.
  • Collaborate with regulatory consultants, clinical advisory boards, and board members to stay informed of US and EU regulatory requirements.
  • Serve as a liaison between Mammoth and regulatory agencies, facilitating communication and ensuring compliance.
  • Coordinate high-quality submissions for global clinical trials, ensuring efficient regulatory processes.
  • Work closely with CMC, nonclinical, and clinical teams to maintain regulatory knowledge and facilitate updates on new regulations and policies.
  • Maintain an understanding of the target patient populations to align therapeutic development.

Required Qualifications:

  • Bachelor’s degree in life sciences (Master’s or PhD preferred)
  • Minimum of 10+ years in biotechnology/biopharmaceutical industry (Master’s with 8+ years or PhD with 6+ years experience).
  • 7+ years in a regulatory capacity with drug development experience, specifically with CBER/OTAT or ex-US clinical trial submissions.
  • Proven track record in regulatory agency interactions and drug development process.
  • Strong experience with gene therapy regulatory requirements.
  • Ability to work onsite in the Bay Area 2-3 times per week.

Preferred Qualifications:

  • Advanced degree in life sciences
  • Creative problem-solving abilities

Benefits:

  • Company-paid health, vision, dental benefits
  • Unlimited vacation and generous sick time
  • Company-sponsored meals and snacks
  • Wellness, caregiver, and ergonomics benefits
  • 401(k) with company matching
  • Base Salary Range: $205,000 - $260,000 (dependent on experience)
  • Mammoth offers a comprehensive benefits package alongside competitive salary options.

Equal Opportunity:
Mammoth Biosciences is committed to providing equal opportunities and will consider all applications regardless of race, color, religion, gender, sexual orientation, or other protected status.