Senior Regulatory Expert (m/f/d)

ABX-CRO is a privately owned, internationally operating, clinical and pre-clinical contract research organisation. Since 2002, we are providing a wide variety of services to customers in pharmaceutical, biotechnology, medical device and medical supply industries, ranging from pre-clinical proof of-concept studies to planning, conducting and analysis of clinical trials on innovative treatments for patients with unmet medical needs. Our long-term experience with molecular imaging and radiology for development of both diagnostics and therapeutics has created an important company focus, particularly in oncological and neurological disease areas. In addition to clinical research, we develop innovative software solutions for molecular radiotherapy applications. For our growing team of experts, we are currently looking for a:

Senior Regulatory Expert with Strategy Experience EMA/FDA (m/f/d)

Full-time permanent position

YOUR TASKS AND RESPONSIBILITIES

  • Provide operational and strategic regulatory input for development programs in USA and EU
  • Contact person for the communication with the EMA and FDA
  • Track and evaluate regulations and standards
  • Support of international product registrations
  • Represent regulatory affairs in company projects
  • Support maintenance of regulatory affairs database
  • Support internal and external audits

YOUR QUALIFICATIONS

  • Bachelor or Master degree in life sciences, e.g. biochemistry, chemistry, biology or related pharmaceutical fields
  • 5+ years of relevant biopharmaceutical industry experience, with 3+ years’ experience in strategy during new drug development
  • Appropriate knowledge of drug and biologics development regulations and guidelines including EMA and FDA guidelines as appropriate for level
  • Excellent regulatory operations skills, including planning and organising

WHAT WE OFFER

  • Diverse tasks in an exciting, international working environment
  • Development potential in an innovation-oriented team with flat hierarchies
  • Flexibility in working hours and distribution of tasks according to individual strengths
  • An international, growing team with well above-average length of service
  • In-house training and active support for your individual training needs
  • Attractive remuneration based on your personal responsibility in project operations

Please contact Dr. Ulrike Schorr-Neufing by e-mail (jobs@abx-cro.com) for further information. If you are interested and you believe to be the right person to join our team, please send us your job application, including your CV, references and salary expectations via e-mail to jobs@abx-cro.com. Please compile your application letter and all supporting documents into a single PDF.

Not exactly the position you are looking for?

For more job offers, please visit: https://www.abx-cro.com/jobs/