Line Manager / Regulatory Affairs Manager United States

Resourcing Life Science; Massachusetts; Hybrid; USD 100,000 - 140,000; Full time

Job summary

A leading life sciences firm in Massachusetts is seeking an experienced Regulatory Affairs Manager to oversee global compliance and regulatory submissions. The ideal candidate will have over 8 years in regulatory affairs, with at least 4 years in a managerial role and experience in EMEA and FDA regulations. Strong English communication skills are essential, and the position requires in-office availability for 4 days a week. Join a dynamic team managing product registrations globally.

Qualifications

• Minimum 8 years in regulatory affairs.
• At least 4 years as Regulatory Affairs Manager.
• Experience with EMEA / FDA regulatory requirements.
• Ideally has line management experience.

Responsibilities

• Manage regulatory submission timelines for products.
• Engage with regulatory authorities for product registrations.
• Conduct global regulatory impact assessments.
• Act as regulatory representative in cross-functional teams.

Skills

Regulatory compliance

English proficiency

Team management

Global market experience

Job description

What to Expect

• Line management, training of Regulatory Specialist
• Training of the direct reports in EMEA / FDA requirements
• Establish and manage regulatory submission timelines for both new and existing products across key global markets
• Engage with regulatory authorities and distribution partners to support product registrations
• Conduct global regulatory impact assessments for product and manufacturing changes through the document control process; prepare and submit required regulatory updates.
• Act as the regulatory representative on cross‑functional teams, collaborating with product development and manufacturing to integrate regulatory requirements throughout the product lifecycle.
• Interpret and apply international regulations, standards, and directives to ensure ongoing global compliance
• Support and participate in inspections and audits conducted by global regulatory authorities.

Requirements

• Min 8 years in regulatory affairs
• Min 4 years as Regulatory Affairs Manager
• Experience with EMEA / FDA regulatory requirements
• Ideally line management of a team
• Excellent written and verbal in English
• Availability to work 4 days in the office

If you have difficulty in applying, have any questions or you cannot find what you are looking for please contact us on 0044 (0) 207 421 0000 or email [e-mail]