Manager, Regulatory Affairs (CMC & Clinical)

About the position The Manager, Regulatory Affairs will support the development and execution of regulatory strategies for assigned programs, with a balanced focus on CMC and Clinical Regulatory Affairs. This role will serve as a key regulatory contributor on cross-functional project teams and support interactions with U.S. and global health authorities under the direction of senior regulatory leadership. The position emphasizes hands-on regulatory execution, document preparation, and cross-functional coordination across clinical development and CMC activities from IND through early commercialization. Location: Remote Responsibilities • Contribute to regulatory strategy development for assigned programs under the guidance of senior regulatory leadership. • Identify and communicate regulatory considerations, risks, and mitigation strategies related to CMC and Clinical activities in a phase-appropriate manner. • Support global regulatory planning across development stages (IND through post-approval). • Draft, review, and coordinate regulatory documents for submissions including INDs, IND amendments, annual reports, briefing documents, IBs, and responses to health authority requests. • Support the preparation of clinical and CMC sections of regulatory submissions ensuring accuracy, clarity, and compliance with applicable regulations (FDA, EMA, ICH). • Ensure regulatory documents meet quality, formatting, and submission readiness standards. • Provide regulatory input to CMC teams related to manufacturing changes, comparability, specifications, and lifecycle management. • Review clinical documents including protocols, ICFs, CSRs, DSURs, and study plans to ensure regulatory compliance. • Support alignment between clinical development plans and CMC readiness. • Act as a regulatory representative on project teams, working closely with Clinical Development, CMC, Quality, Nonclinical, and Regulatory Operations. • Coordinate regulatory activities and timelines to support development milestones. • Prepare internal regulatory updates and contribute to team presentations as needed • Support preparation for health authority meetings, including briefing packages and Q&A documents. • Participate in agency communications as appropriate, under the direction of senior regulatory leadership. • Ensure compliance and regulatory obligations are handled in accordance with SOPs and applicable regulations. • Maintain up-to-date knowledge of regulatory guidelines and industry trends relevant to CMC and clinical development. Requirements • Bachelor’s degree in a scientific or related discipline. • Five (5) years of regulatory affairs experience in pharmaceutical or biotechnology development. • Demonstrated experience supporting IND-stage and/or clinical development programs. • Experience drafting regulatory documents and supporting regulatory submissions • Working knowledge of CMC and clinical regulatory requirements. • Familiarity with eCTD structure and regulatory documentation standards Benefits • HIGHLY COMPETITIVE SALARIES • ANNUAL PERFORMANCE/MERIT REVIEWS • ANNUAL PERFORMANCE BONUSES • EQUITY • SPECIAL RECOGNITION • FULLY REMOTE WORK ENVIRONMENT • REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off • HOLIDAYS –In 2025 we will observe 14 holidays • RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary • HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal • HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC • ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans • LIFE INSURANCE – Company Paid 1 x base salary + Voluntary Plans • ADDITIONAL EXCLUSIVE BENEFITS – Voluntary Legal, Pet, Plus More Apply tot his job Apply To this Job