Senior Regulatory Affairs Manager & Line Lead (EMEA/FDA)

Resourcing Life Science; Denmark; On-site; DKK 900,000 - 1,100,000; Full time

Job summary

A leading life sciences recruitment firm in Denmark is seeking an experienced Regulatory Affairs Manager to oversee regulatory submissions and compliance. This role requires a minimum of 8 years in regulatory affairs, with at least 4 years in management. Candidates should be familiar with EMEA and FDA requirements and possess excellent English communication skills. The position entails 4 days of work in the office, with responsibilities including managing submission timelines and engaging with regulatory authorities.

Qualifications

• Minimum 8 years in regulatory affairs.
• Minimum 4 years as Regulatory Affairs Manager.
• Experience with EMEA / FDA regulatory requirements.

Responsibilities

• Line management and training of Regulatory Specialist.
• Establish and manage regulatory submission timelines.
• Engage with regulatory authorities for product registrations.

Skills

Regulatory affairs

EMEA / FDA requirements

Line management

Excellent written and verbal English

Job description

A leading life sciences recruitment firm in Denmark is seeking an experienced Regulatory Affairs Manager to oversee regulatory submissions and compliance. This role requires a minimum of 8 years in regulatory affairs, with at least 4 years in management. Candidates should be familiar with EMEA and FDA requirements and possess excellent English communication skills. The position entails 4 days of work in the office, with responsibilities including managing submission timelines and engaging with regulatory authorities.