Manager, Regulatory Affairs

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

📋 Description

• Assist in global regulatory efforts throughout both early- and late-stage development programs via lifecycle management.

• Collaborate across various functions to ensure high-quality regulatory submissions.

• Facilitate effective interactions with global health authorities.

• Support the regulatory strategy and execution for INDs, CTAs, NDA components, supplements, and other related regulatory activities.

• Prepare, review, and submit regulatory documents, including INDs/CTAs, amendments, information requisitions, Orphan drug applications, Annual Reports, and Investigator’s Brochures.

• Aid in the coordination and preparation of documents for meetings with global health authorities.

• Contribute to global regulatory strategy and ensure that submissions comply with health authority standards and quality requirements.

• Act as the representative for Regulatory Affairs in global study-level tasks, encompassing study initiation, maintenance, and closure activities.

• Work alongside external partners and vendors on regulatory initiatives and submission support.

• Support regulatory operations and continuous improvement projects, including the development and upkeep of work instructions and SOPs.

⛳️ Requirements

• Bachelor’s degree, ideally in a scientific field.

• Over 6 years of experience in the pharmaceutical industry.

• At least 4 years of experience in Regulatory Affairs.

• In-depth knowledge of U.S. and international regulatory standards for drug development.

• Exceptional verbal and written communication abilities.

• Strong organizational capabilities.

• Excellent skills in cross-functional collaboration.

• Proven experience in a self-driven, fast-paced environment.

• Experience in supporting initial INDs/CTAs and initial marketing application processes is highly preferred.

🏝️ Benefits

• Equity-based compensation.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan with company matching.

• Life insurance.

• Flexible spending account for health and/or dependent care.

• Annual performance bonus.

• Long-term incentive plan.

• Generous parental leave.

• Family planning benefits.

• Opportunities for personal and professional growth.