Regulatory Affairs Senior Specialist

Regulatory Affairs Senior Specialist

Bavarian Nordic

Martinsried, Germany

Your tasks

  • Coordinate, compile and assist in the preparation and writing of regulatory documents and filings in support of CTAs, INDs, MAAs, Variations in eCTD format;
  • Coordinate pre- and post-licensing submission activities across projects including coordination of the Health Authority response team;
  • Maintain product information to support post-licensing activities (i.e. EMA and Health Canada);
  • Responsible for assigned tasks with limited manager oversight;
  • Responsible for Regulatory Intelligence: identification and communication of changes in the global regulatory landscape.

Your profile

  • University degree (at least BSc or equivalent) in life-science (e.g. biology, molecular biology, biochemistry, pharmacy, etc.);
  • At least 4 years of related experience in regulatory affairs (drug development);
  • Solid understanding of regulatory submission and approval process with familiarity with at least one major Health Authority (e.g. Europe, Canada);
  • Computer proficiency (MS Office, Adobe Acrobat);
  • Excellent verbal and written communication skills in English;
  • Ability to effectively work according to deadlines;
  • Excellent interpersonal skills, ability to work as a member of a team and independently.

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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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