Line Manager / Regulatory Affairs Manager Denmark

Resourcing Life Science; Denmark; Hybrid; 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.
• Availability to work 4 days in the office.
• Excellent written and verbal in English.
• Ideally line management of a team.

Responsibilities

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

Skills

Regulatory affairs

EMEA / FDA requirements

Line management

Excellent written and verbal English

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]

Tagged as: Regulatory Affair