Associate Director, Regulatory Affairs CMC

This is a fully remote position, open to applicants in California.

📋 Description

• Oversee the creation and execution of global CMC regulatory strategies for small-molecule products throughout their development, registration, commercialization, and post-approval lifecycle management.

• Act as the principal Regulatory CMC partner for Pharmaceutical Development, Manufacturing, Quality, Supply Chain, and other cross-functional teams.

• Offer regulatory guidance regarding drug substance and drug product manufacturing, formulation, manufacturing processes, analytical methods, specifications, stability, packaging, container closure systems, and related CMC activities.

• Evaluate proposed manufacturing and product modifications, and formulate global regulatory strategies and implementation plans.

• Provide regulatory support for manufacturing scale-up, process optimization, technology transfers, changes in manufacturing sites, formulation alterations, specification updates, analytical method adjustments, packaging modifications, and other product lifecycle activities.

• Counsel CMC and Quality teams on the regulatory implications of change controls.

• Identify CMC regulatory risks and deliver risk-based recommendations that support compliance, product quality, and the continuity of commercial supply.

• Review, author when necessary, and coordinate CMC content for NDAs, amendments, supplements, annual reports, health authority responses, and other CMC-related submissions.

• Lead the preparation and review of post-approval CMC submissions, including PAS, CBE/CBE-30, Annual Reportable changes, and other U.S. reporting categories.

• Formulate and implement global post-approval change strategies, encompassing EU Type IA, Type IB, and Type II variations.

• Utilize SUPAC, FDA, EMA, ICH, and other global regulatory guidelines.

• Review CMC documentation from technical functions, contract manufacturers, testing laboratories, and external partners.

• Ensure the consistency of CMC data across submissions, source documents, approved applications, and global dossiers.

• Assist in the preparation and maintenance of Module 3 and other CMC components of global regulatory applications.

• Aid in responses to health authority CMC inquiries and information requests.

• Provide regulatory leadership for CMC lifecycle management of commercially marketed products.

• Assess changes in manufacturing, processes, sites, equipment, formulations, analytical methods, specifications, stability, packaging, and supply-chain logistics.

• Integrate regulatory requirements into pharmaceutical change-control processes.

• Develop global implementation strategies that consider variations in approval timelines and reporting obligations.

• Stay informed on regulatory commitments, approved conditions, and country-specific regulations.

• Lead or assist in CMC interactions with the FDA and other global health authorities.

• Create briefing materials, regulatory positions, responses, and supporting documentation for health authority meetings and written correspondence.

• Represent Regulatory CMC in discussions about manufacturing changes, comparability, specifications, analytical methods, stability, process validation, and other CMC-related topics.

• Keep abreast of evolving regulations and guidance from the FDA, EMA, ICH, and other global CMC authorities.

• Support regulatory evaluations of investigations, deviations, out-of-specification trends, manufacturing changes, and other quality or technical issues.

• Provide regulatory insights into comparability strategies and supporting data packages for post-approval manufacturing changes.

• Communicate regulatory updates and emerging expectations to CMC and senior leadership.

⛳️ Requirements

• A Bachelor's degree in Chemistry, Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Biology, or a related scientific field is required.

• An advanced scientific degree such as an MS, PharmD, or PhD is preferred.

• A minimum of 10 years of experience in Regulatory Affairs within the pharmaceutical or biopharmaceutical industry, with considerable focus on CMC regulatory affairs.

• Proven experience in Regulatory CMC for small-molecule drug products is required.

• Prior experience supporting commercially marketed products and managing post-approval CMC lifecycle is essential.

• Demonstrated knowledge of U.S. post-approval change requirements, including SUPAC, PAS, CBE/CBE-30, and Annual Reportable changes.

• Strong understanding of global post-approval regulatory obligations, including EU variation classifications and processes (Type IA, IB, and II).

• Proven track record in preparing, reviewing, and managing CMC sections of NDAs and other marketing applications, supplements, variations, amendments, and responses to health authority inquiries.

• Solid understanding of small-molecule pharmaceutical development and manufacturing, encompassing drug substance and drug product manufacturing, process validation, scale-up, technology transfer, analytical methods, specifications, stability, and packaging.

• Experience in assessing the regulatory impact and reporting requirements for changes in manufacturing sites, processes, formulations, analytical methods, specifications, scale, and other commercial manufacturing alterations.

• Comprehensive knowledge of FDA, EMA, ICH, and other major global CMC regulatory requirements and guidelines.

• Experience collaborating with internal manufacturing teams, Quality functions, CMOs/CDMOs, testing laboratories, and other external technical partners.

• Previous direct interaction with the FDA and/or other global health authorities on CMC issues is preferred.

• Experience with solid oral dosage forms is preferred.

• Exceptional scientific and regulatory judgment with the capability to independently evaluate complex CMC changes and translate technical information into straightforward regulatory strategies.

• Excellent technical writing and regulatory submission writing skills.

• Strong critical-review abilities and a proven capacity to identify gaps, inconsistencies, and regulatory risks within CMC documentation.

• Ability to provide clear, actionable regulatory advice to CMC, Quality, Manufacturing, Supply Chain, and senior leadership.

• Strong written and verbal communication skills with the ability to influence cross-functional teams.

• Detail-oriented, proactive, and capable of managing multiple priorities in a dynamic, matrixed environment.

• Strong organizational and project management skills with a demonstrated ability to handle multiple submissions and global implementation timelines.

• Experience effectively collaborating across global teams and time zones.

🏝️ Benefits

• Annual incentive bonuses.

• Equity participation.

• Health insurance.

• Dental insurance.

• Vision insurance.

• 401(k).

• Paid time off.

• Reasonable accommodations for individuals with disabilities.