Consultant Regulatory Affairs

Consultant Regulatory Affairs

ProPharma Group

Berlin, Germany

Job Description

  • Providing regulatory advice in regards to pre- and post-marketing regulatory activities to a variety of clients;
  • Preparation and submission of applications for marketing authorisations and variations including response to deficiency letters;
  • Regulatory CMC writing of CTD-Modules 2.3 & 3 or Medical writing of Clinical Overviews/Addenda to Clinical Overviews or drafting of product information texts and maintaining CCDS;
  • Communication with regulatory authorities;
  • Preparation of briefing documents for scientific advice procedures;
  • Managing projects;
  • Maintaining and building client relationships.

Qualifications

  • You hold a university degree in Pharmacy, Chemistry, Biochemistry, Biology, ideally with a PhD;
  • You have experience in the pharmaceutical industry in roles such as Regulatory Affairs, Quality, Product Development or Pharmacovigilance or in a competent regulatory authority;
  • You have an excellent understanding of the regulatory requirements for medicinal products in the EU and of product life cycle;
  • You have experience in preparing and submitting documentation for regulatory authorities;
  • You are able to maintain high quality, accuracy and consistency in your work and deliver on your commitments;
  • You are willing to undertake business travels to clients and other ProPharma Group sites;
  • You have a positive attitude and are able to work well within a team;
  • You are able to work independently with less supervision, take initiative and make decisions based on company guidelines;
  • You are able to work on multiple projects, prioritize and meet project deadlines;
  • You are an excellent communicator and have the ability to work with all levels of the company;
  • You have excellent German and English skills.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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