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Associate Director Regulatory Affairs - Paris (75)

Business Type: Biotechnology Company
Job Type: Regulatory Affairs
Job Level: Senior Executive
Position: Full Time
Salary: Bonus + avantages
Location: France
Reference: AR-282829
Closing Date: 26/04/21
Job Details:

Associate Director Regulatory Affairs - Paris (75)

One of the most advanced and innovative biotech in the world is creating a position as Associate Director Regulatory Affairs to reinforce the team and work on the many projects they are in the pipeline.

They are finalizing several products in clinical stage, ready to submit in US and EU. Their first-in-class technology is focus on fighting different types of cancers, and improve the patients well-being.

You will have the chance to work in a company with less than 100 employees, where you can bring your regulatory skills to the table while continuing to develop your skills.

Main missions (not limited to) :

  • To realize all the activities linked to the registration and the maintenance of medical devices and drugs on the worldwide market in compliance with the regulations, from the development phase to the products end of life.
  • To implement the regulatory affairs strategy of the company to ensure the enforcement and compliance of/with regulations from the development phase to the products end of life.
  • Develop the regulatory strategy for the submission of clinical trials following the directives of the Director, Global Head Regulatory Affairs,
  • Be the privileged interlocutor of the Health Authorities and Ethics Committees in France and in the countries which allow it for the regulatory acts linked to clinical trials.
  • Submit the files for registration and maintenance of clinical trials directly to the Health Authority and Ethics Committees in France and in the countries which allow it (initial recording, amendments, trail closure) ·
  • Send the files for registration and maintenance of clinical trials to the local regulatory representatives of countries when required, ensure the follow-up and bring all the support until obtaining of the approval.
  • Coordinate and prepare the answers to the requests of the regulatory authorities.
  • Submit the answers to the requests of the regulatory authorities or send them to the local representatives and ensure the follow-up until obtaining of the approval.
  • If necessary, negotiate with external agencies to solve the crucial regulatory problems in agreement with the Director, Global Head Regulatory Affairs.
  • Drive the "New medical device or drug registration" project meeting and coordinate the activities to ensure all the involved functions have all the information needed to obtain the registration dossier or the maintenance dossier or the answers to questions dossier in the defined timelines,
  • ...

Profile :

  • Postgraduate qualification (PhD or research-based MSc), or Bachelor''s degree in a scientific discipline or equivalence,
  • Advanced degree or Regulatory Affairs Certification is preferred,
  • Extensive knowledge of international medical device regulatory clearance processes or medicine products approval is a must,
  • Have a very good knowledge of the regulations applicable to its business area,
  • Have a scientific knowledge related to the company''s products in order to understand the technical documentation that support the regulatory submissions.
  • A minimum of ten (10) years of regulatory experience a similar position in the medical device, biotechnology field or pharmaceutical industry,
  • Experience with European authorities and/or FDA interactions.

NonStop Consulting Limited Posted by:: NonStop Consulting Limited (View all our vacancies)
Unless otherwise stated, if applying for a job, you must ensure that you are already authorised to work in the country in which the job is based
Posted: 19/04/2021 | NPJ Ref: 269277
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