Germany Regulatory Affairs Specialist: Lifecycle Compliance

Groupe ProductLife; Germany (OH); On-site; USD 57,038 - 79,853; Full time

Job summary

Groupe ProductLife is looking for a Regulatory Affairs Specialist to manage compliance for Germany and EU markets. You will prepare and submit Marketing Authorisation Applications, ensure product lifecycle compliance, and interact with Health Authorities.

The ideal candidate has a relevant life science degree, 2-5 years in Regulatory Affairs, and strong organizational skills. This role requires proactive communication and the ability to manage multiple responsibilities effectively.

Qualifications

• 2-5 years of relevant Regulatory Affairs experience required.
• Proven interaction with Health Authorities necessary.
• Experience in consultancy or multi-client settings is advantageous.

Responsibilities

• Prepare and submit Marketing Authorisation Applications for Germany.
• Ensure compliance with documentation throughout product lifecycle.
• Act as key contact with Health Authorities for regulatory queries.

Skills

German Regulatory Affairs

Product Lifecycle Management

Excellent organizational skills

Communication skills

Pro-active mindset

Education

Degree in a relevant life science discipline

Tools

Microsoft Office Suite

Veeva Vault

TrackWise

Job description

Groupe ProductLife is looking for a Regulatory Affairs Specialist to manage compliance for Germany and EU markets. You will prepare and submit Marketing Authorisation Applications, ensure product lifecycle compliance, and interact with Health Authorities.

The ideal candidate has a relevant life science degree, 2-5 years in Regulatory Affairs, and strong organizational skills. This role requires proactive communication and the ability to manage multiple responsibilities effectively.