Senior Manager/Associate Director, Regulatory CMC

Job Title: Senior Manager/Associate Director, Regulatory CMC

Location: San Francisco, CA (Remote)

Position Type: Full-time

Position Summary:

The role involves spearheading the development of strategies concerning chemistry, manufacturing, and control (CMC) regulations for both small and large molecule pharmaceuticals and devices, ensuring compliance with global regulatory standards across product lifecycles. Responsibilities include crafting or authoring CMC regulatory submissions for investigational, commercial, and post-approval phases, actively engaging in health authority interactions, evaluating the impact of new regulations, and more.

This position will offer guidance and direction in interpreting and implementing global CMC regulations.

Key Responsibilities:

• Act as the lead Regulatory CMC representative within cross-functional teams, providing regulatory insights to aid global product development.
• Devise and implement comprehensive global CMC regulatory strategies for one or multiple drug products.
• Review and prepare regulatory submissions for clinical and commercial products, encompassing INDs, IND amendments, annual reports, DSURs, post-approval supplements, and variations.
• Take the lead in compiling regulatory dossiers for submission to relevant health authorities such as the FDA.
• Develop and align on the regulatory CMC strategy with project teams for addressing Health Authority inquiries.
• Serve as the primary contact point for FDA and other Health Authorities regarding designated projects.
• Assess and provide feedback on technical reports supporting clinical investigations and marketing applications.
• Offer precise regulatory assessments on CMC changes and their global implications for ongoing and existing submissions, furnishing strategic regulatory advice for optimal change implementation.
• Keep abreast of the global competitive landscape, regulatory frameworks, guidelines, and CMC directives, interpreting and disseminating this information to internal stakeholders while initiating process enhancements as appropriate.

Education & Qualifications:

• Academic background in the life sciences (minimum BS degree or equivalent) with 5-8 years’ experience in regulatory affairs; advantageous to have experience with biological products.
• Desirable experience with devices and/or radiopharmaceutical drugs.
• In-depth familiarity with prevailing and evolving FDA, ICH, and other pertinent regulations and guidance documents.
• Proficiency in preparing INDs, amendments, NDAs/BLAs, and submissions in CTD format.
• Experience in liaising with the FDA, handling meeting requests, briefing book requirements, and adhering to timelines.
• Ability to manage multiple priorities and adapt to shifting deadlines.
• Exceptional oral and written communication skills.
• Strong planning, organizational, and prioritization capabilities.
• Proficient in MS Word, PowerPoint, and experience with Adobe Acrobat Professional.
• Work Environment: The role is not location-specific. It allows for a hybrid working setup in which remote work is possible with periodic travel (10-25%) if needed for certain commitments.