Job Description

This is a U.S. (Boston-based) regulatory affairs coordination role with a well-established EU-based life science company that is expanding its footprint in the United States. The position serves as the primary regulatory representative in the U.S., ensuring compliance with FDA regulations and facilitating communication between the U.S. market, U.S. customers, and the company’s global regulatory team based in the EU. The ideal candidate will be proactive, detail-oriented, and capable of working effectively across international and functional boundaries.

Key Responsibilities

• Serve as the U.S. Agent for the company’s sites, fulfilling all regulatory duties and maintaining strong knowledge of relevant CFR sections for medicinal products.
• Ensure timely and compliant Drug Listing and Facility Registration submissions in accordance with FDA regulations.
• Prepare and submit required data under the FDA CARES Act, ensuring alignment with regulatory obligations.
• Obtain and maintain necessary federal and state permits and licenses, including preparing applications as needed.
• Support regulatory and quality-related requests from customers and final applicants.
• Collaborate with Sales to support business goals through aligned regulatory activities.
• Maintain an up-to-date database of customers’ regulatory filing status.
• Recommend strategies to accelerate clearance of imported materials through U.S. Customs and FDA.
• Stay informed and provide updates on U.S. regulations and guidelines relevant to the company’s operations.

Key Skills

• Strong knowledge of regulatory frameworks and guidelines governing drug development and approval (e.g., USP, FDA, CFR), with the ability to interpret both legal and scientific requirements.
• Excellent analytical thinking, problem-solving ability, and a quick grasp of complex scientific concepts across diverse disciplines.
• Collaborative team player with leadership qualities; able to motivate, lead, and work effectively with cross-functional teams.

Other Aspects of the Role

• Educational Qualification: A degree in a relevant scientific discipline is required, preferably in the life, physical, or medical sciences.
• Location of position: This role is hybrid with presence required at the Boston Office up to 2 days a week.
• Remuneration and career progression: The successful candidate will be offered a competitive salary in addition to a performance-related bonus.

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Legal

Industries

• Staffing and Recruiting

Job Tags

Similar Jobs