Senior Regulatory Affairs Consultant
vor 4 Wochen
GULP – experts united is currently seeking a Regulatory Affairs Specialist for a partner in the pharmaceutical sector. We prioritize a secure and equitable salary along with comprehensive social benefits, ensuring a responsible role with a long-term vision. Your satisfaction is our priority.
What We Offer
- Competitive salary and job stability through group affiliation
- Comprehensive social benefits, including holiday and vacation bonuses
- Up to 30 days of vacation entitlement annually
- Discounts on sports, leisure, and wellness activities
- Clear definition of career objectives
Key Responsibilities
- Planning, organizing, and executing national procedures for new marketing authorizations, renewals, and variations for medicinal products
- Collaborating on European procedures (MRP, DCP, CP) for medicinal products in close coordination with the European authorization team
- Implementing regulatory and safety-related requirements in product texts for medicinal products
- Conducting regulatory assessments of projects to obtain and amend marketing authorizations
- Serving as a liaison to national authorities and departments such as Marketing, CMC, PV, and Quality
Your Profile
- Degree in natural sciences (e.g., chemistry, biology), pharmacy, or medicine is preferred
- Master’s degree in Drug Regulatory Affairs is desirable
- Several years of experience in regulatory affairs within the pharmaceutical industry
- Strong knowledge of relevant legislation for medicinal products
- Proficient in electronic submissions and internet-based systems
- Excellent written and spoken skills in both German and English
- Strong analytical abilities, process-oriented thinking, and effective communication skills
- Good organizational and teamwork capabilities, with a reliable, independent, structured, and precise working style
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