Vetter Pharma

Regulatory Affairs Specialist

Vetter Pharma

full-time

Posted on:

Location Type: Office

Location: Ravensburg • 🇩🇪 Germany

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Job Level

Mid-LevelSenior

About the role

  • You prepare, review and update pharmaceutical documentation (CMC; Module 3) for marketing authorization dossiers (MAA, NDA/BLA) as well as for clinical trial materials (IND/IMPD) — in accordance with national and international requirements (e.g. EMA, FDA)
  • You work closely with international clients on projects and across the entire product lifecycle
  • You are responsible for preparing and regularly updating Drug Master Files for our Vetter closure systems (e.g. V-LK S, V-OVS) in line with the requirements of international regulatory authorities
  • You act as a point of contact for regulatory authority inquiries, deficiency letters, as well as customer and internal regulatory queries
  • You contribute proactively by presenting regulatory topics internally and externally, conducting information sessions and training, and driving projects to increase efficiency and optimize processes

Requirements

  • Completed degree in Pharmacy, a natural science, or a technical field
  • Initial professional experience in a regulated environment, ideally in a GMP setting
  • Additional qualification in Regulatory Affairs (e.g. DGRA) — advantageous
  • Fluent English skills, both written and spoken
  • Analytical and structured working style to ensure our high quality standards
  • Strong team player with a pronounced customer- and partner-oriented approach
  • Good German skills (at least C1 level) to document your work effectively and communicate with the team
Benefits
  • Independent, interdisciplinary work in a family-run company with modern workplaces and innovative technologies
  • Strong team and career opportunities — idea exchange and many training and development opportunities at one of the leading pharmaceutical service providers
  • Attractive compensation — our remuneration package consists of a fixed salary, variable pay, tailored benefits, and a company performance bonus awarded to each employee when company targets are met. This also includes shift and overtime premiums and vacation pay
  • Fair work–life balance — at least 30 days of vacation, flexitime, family-friendly measures, and the possibility for partial remote work
  • Vetter benefits — an ideal combination of company pension scheme and time-value accounts, e.g. supplementary company health insurance
  • Occupational health management with fitness and sports offers (EGYM Wellpass)
  • Personal perks (Deutschland-Ticket, Vetter holiday homes, JobRad bike leasing, employee discounts, and more)

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
pharmaceutical documentationmarketing authorization dossiersclinical trial materialsDrug Master FilesGMPRegulatory Affairsanalytical skillsstructured working style
Soft skills
team playercustomer-orientedpartner-orientedcommunication skillspresentation skillstraining skillsproactive contribution
Certifications
degree in Pharmacydegree in natural sciencedegree in technical fieldRegulatory Affairs qualificationDGRA