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Associate Director / Director, Regulatory Affairs
Associate Director / Director, Regulatory AffairsMeet Recruitment • San Francisco, CA, United States
Associate Director / Director, Regulatory Affairs

Associate Director / Director, Regulatory Affairs

Meet Recruitment • San Francisco, CA, United States
30+ days ago
Job type
  • Permanent
Job description

Overview

Associate Director / Director, Regulatory Affairs

Electra857 Posted : 03 / 09 / 2025

  • Salary : $190,000 - $250,000
  • Location : San Francisco, United States
  • Employment Type : Permanent

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

Responsibilities

  • Report to the Senior Vice President Regulatory Affairs and drive the implementation of regulatory strategies in collaboration with US and EU regulatory leads; provide strategic input across programs.
  • Contribute to regulatory plans and strategies, identify and propose risk mitigation to facilitate progress for assigned programs in all development phases.
  • Develop and implement strategies for earliest possible approvals / clearances of regulatory submissions for assigned projects.
  • Support early-stage regulatory activities with a strong focus on CMC-related aspects, including pre-IND, IND, and CTA preparation and submissions; maintain CMC foundation while broadening regulatory scope.
  • Act as a regulatory generalist with clinical development alignment, contributing to regulatory strategy and documentation from early development through Phase I–III, including Type C meetings and change control oversight.
  • Provide strategic input on CMC activities and support global regulatory filings and interactions (e.g., CDISC standards).
  • Serve as the Regulatory Affairs representative on assigned project teams, guiding and facilitating regulatory approvals.
  • Prepare and / or manage submissions that may be technically complex and require cross-functional interaction beyond regulatory affairs.
  • Provide regulatory advice to cross-functional teams (CMC, nonclinical, clinical) to support product development and timely achievement of goals.
  • Lead drafting, review, and finalization of responses to queries from Regulatory Authorities.
  • Maintain awareness of current regulatory requirements and communicate changes to support regulatory approvals.
  • Establish and meet timelines for regulatory submissions related to INDs / CTAs, including nonclinical, clinical, and CMC activities.

    • Education & Professional Experience

  • A degree in life science, chemistry, chemical engineering, or closely related discipline (graduate degree preferred) with 8-10+ years in biotechnology / pharmaceutical regulatory affairs; experience in fast-paced, small company environment and biologics preferred.
  • Regulatory Submissions & Approvals : Proven track record of drafting and finalizing submissions (IND / CTA, NDA / BLA / MMA) with direct CMC-focused regulatory submissions and product approvals; strong knowledge of FDA regulations, ICH guidance, and global health authority practices in US and Europe (UK experience a plus).
  • Skills & Proficiency : Proficient in MS Word, Excel, PowerPoint, Visio, Adobe Acrobat; excellent verbal and written communication, negotiation, and interpersonal skills.
  • Project & Team Management : Ability to manage multiple complex projects, prioritize, and lead cross-functional regulatory activities; ability to work independently and influence others; prior management experience a plus.
  • Strategic Guidance & Collaboration : Experience providing strategic advice on integrated regulatory development plans and lifecycle management; strong analytical and report-writing skills for regulatory submissions.
  • Regulatory Agency Interactions : Extensive experience leading regulatory agency interactions, with focus on early development programs and CMC discussions.

    • The salary range for this position is $190,000 – $250,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.

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    Director Regulatory • San Francisco, CA, United States

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