Global Regulatory Affairs Line Manager FDA/EMEA Expert

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

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.