FDA Regulatory Affairs Director – Germany

Resourcing Life Science; Deutschland; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Resourcing Life Science in Germany seeks an experienced Regulatory Affairs Manager to lead regulatory activities for global markets. You will manage a team, coordinate submissions, and ensure lifecycle compliance. The ideal candidate has 8+ years in regulatory affairs, 4+ years in management, and strong English skills.

Availability to work four days in the office is required. This role requires liaison with authorities and partners, driving timely registrations and global regulatory updates

Qualifikationen

• 8+ years in regulatory affairs.
• 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.

Aufgaben

• Line management and training of regulatory staff.
• Train reports on EMEA and FDA requirements.
• Establish and manage regulatory submission timelines across markets.
• Engage with regulatory authorities and distribution partners for registrations.
• Assess regulatory impact of product/manufacturing changes and submit updates.
• Represent regulatory on cross-functional teams to integrate requirements.
• Interpret and apply international regulations to ensure ongoing compliance.
• Support inspections and audits by global authorities.

Kenntnisse

Regulatory leadership

Line management

English proficiency

Jobbeschreibung

What to Expect

• Line management, training of Regulatory Specialist
• Training of the direct reports in EMEA / FDA requirements
• Establish and manage regulatory submission timelinesfor both new and existing products across key global markets
• Engage with regulatory authorities and distribution partnersto support product registrations
• Conduct global regulatory impact assessmentsfor 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 auditsconducted 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