Associate Director / Director, Regulatory AffairsMeet Recruitment • San Francisco, CA, United States
Associate Director / Director, Regulatory Affairs
Meet Recruitment • San Francisco, CA, United States
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job_description.job_card.job_descriptionReport 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. 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.
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
Education & Professional Experience
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.
Apply for this role
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Director Regulatory • San Francisco, CA, United States
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