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 Now
Apply Now
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 Now
Apply Now