Regulatory Affairs Specialist

Vor 6 Tagen

Berlin, Berlin, Deutschland GULP – experts united Vollzeit

**About GULP – Experts United**

We are a leading consulting firm specializing in regulatory affairs for the pharmaceutical industry. Our team of experts is dedicated to providing top-notch services to our clients, ensuring compliance with all relevant regulations and laws.

**Job Summary**

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Berlin. As a Regulatory Affairs Specialist, you will be responsible for planning, organizing, and implementing national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for medicinal products.

**Key Responsibilities**

  • Plan, organize, and implement national procedures for new marketing authorizations, marketing authorization renewals, and marketing authorization variations for medicinal products.
  • Collaborate on corresponding European procedures (MRP, DCP, CP) for medicinal products in close cooperation with the European authorization team.
  • Implement regulatory and safety-related requirements in the product texts of medicinal products.
  • Regulatory assessment of projects to obtain and amend marketing authorizations.
  • Act as an interface to national authorities and employees in the Marketing, CMC, PV, and Quality departments.

**Requirements**

  • Degree in natural sciences (e.g., chemistry, biology), possibly also pharmacy or medicine.
  • Degree as Master of Drug Regulatory Affairs desirable.
  • Several years of professional experience in regulatory affairs in the pharmaceutical industry.
  • Good knowledge of relevant legislation for medicinal products.
  • Confident handling of electronic submissions and internet-based systems.
  • Good written and spoken German and English skills.
  • Analytical skills, a high degree of process thinking as well as strong communication and interpersonal skills.
  • Good organizational and teamwork skills as well as a reliable, independent, structured, and precise way of working.

**What We Offer**

  • Attractive salary and long-term job security through group affiliation.
  • Extensive social benefits, including Christmas and vacation bonuses.
  • Vacation entitlement of up to 30 days per year.
  • Discounts at sports, leisure, and wellness facilities.
  • Definition of career goals.

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