Manager, Regulatory Affairs

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

📋 Description

• Assist in the preparation, review, and submission of regulatory filings such as INDs/CTAs, amendments, information requests, Orphan drug applications, Annual Reports, and Investigator’s Brochures.

• Aid in the coordination and development of documents for global health authority meetings.

• Contribute to the global regulatory strategy and ensure that submissions adhere to health authority regulations and quality standards.

• Represent the regulatory team for global study-level activities, including study initiation, ongoing study management, and trial closure activities.

• Collaborate with external partners and vendors on regulatory tasks and submission assistance.

• Support regulatory operations and initiatives for continuous improvement, including the development and maintenance of work instructions and SOPs.

⛳️ Requirements

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

• Over 6 years of experience in the pharmaceutical industry, with at least 4 years in Regulatory Affairs.

• In-depth knowledge of U.S. and international regulatory requirements related to drug development.

• Exceptional verbal and written communication skills, along with strong organizational and cross-functional collaboration abilities.

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

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

🏝️ Benefits

• Competitive salary and annual performance bonus.

• Comprehensive benefits package including medical, dental, and vision insurance, as well as a 401(k) retirement plan with company match, among other perks.

• Generous parental leave and family planning benefits.

• A vibrant company culture with opportunities for both personal and professional development.