Regulatory Affairs Manager - DACH (m/f/x)
package negotiable

Regulatory Affairs Manager - DACH (m/f/x) | Baden - Württemberg Area | Pharmaceutical Industry

Are you a regulatory affairs specialist with a knack for navigating the intricacies of marketing authorizations within a global context? Do you excel in adhering to eCTD/eSubmission standards and thrive on contributing to regulatory strategy development? If you're seeking an opportunity to make a significant impact at a well-established medium-sized pharmaceutical company with international reach, your search ends here!

Key Responsibilities:

  • Taking care of all local RA activities and deliverables within the D-A-CH countries, including regulatory support for AAA Pharma.
  • Fully responsible for DE/AT/CH exclusive licenses (i.e. maintenance, submissions, texts)
  • Fully responsible for initial creation and maintenance of product information texts in German language
  • Evaluation and organization of new and updated product registration application dossiers related to the submission procedure, MAH transfers, renewals and variation procedures in DACH
  • Evaluation of content and regulatory quality especially for the administrative documentation (Module 1)
  • Responsible for the complete maintenance and lifecycle management activities of the exclusive licenses in DACH
  • Collaboration with other teams/departments in regulatory affairs relevant projects and assessment of regulatory questions
  • Review, update, correction and submission of regulatory documentation after receiving the documents from the respective department for the exclusive licenses in DACH
  • Participation in regulatory affairs related projects regarding developing of new products and supporting TTs for the exclusive licenses in DACH
  • Consistent updating of legislation requirements in DACH region.
  • Excellent knowledge of the technical & regulatory requirements and experience regarding the registration & life cycle management (inter alia tech/site transfers, product information changes, product optimization etc.) of medicinal products with special focus on EU and the D-A-CH countries.
  • At least a basic understanding for the regulatory requirements for food supplements in EU/D-A-CH.
  • Negotiate approaches & responses to health authorities in a manner acceptable to both the regulatory agency and the company demonstrated by a proven track record of ensuring registrations / variations are successfully approved.
  • Management, tracking and prioritization of daily business tasks.


  • Bachelor's or master's degree in pharmacy, (veterinary) medicine, or related natural sciences.
  • Preferably, a Master's in Drug Regulatory Affairs.
  • 3+ years of regulatory affairs experience in the pharmaceutical industry or food supplements sector.
  • Strong understanding of registration and lifecycle management activities.
  • Proven experience in negotiating and communicating with regulatory authorities.
  • Proficiency in Regulatory Information Management Systems & Databases.
  • Solid project management skills.
  • Demonstrated reliability, teamwork, initiative, cross-functional collaboration, and multitasking abilities.
  • Excellent written and verbal English; proficiency in German and other languages is advantageous.


  • Competitive salary package inclusive of base salary and 13th-month salary.
  • Permanent employment contract.
  • Generous annual leave entitlement of 30 days.
  • Flexible part-time working arrangement (up to 25 hours per week).
  • Convenient accessibility via public transport and ample parking availability.
  • Flexible start date with the option for up to 40-60% remote work.

Interested in this Opportunity?

If you're eager to leverage your expertise in regulatory affairs within a dynamic pharmaceutical environment, we encourage you to submit your application today! We're also open to considering applications for alternative positions within our organization.

My contact details:

We eagerly await your application!

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