62 days ago on jobs.actelion.com

Senior International DRA Project Manager

Actelion Pharma Schweiz AG

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Senior International DRA Project Manager

Senior International DRA Project Manager - (160000GG)


About the Company


Actelion Pharmaceuticals Ltd. is a leading biopharmaceutical company employing over 2,500 dedicated professionals covering all key markets around the world – including Europe, the US, Japan, China, Russia and Mexico. Headquartered in Allschwil, near Basel, Switzerland, our functional, award-winning Actelion Center is a symbol of our innovative spirit and culture.


We are searching for breakthrough medicines for high unmet medical needs and this inspires and motivates all of us to work towards achieving our overriding mission: to treat more patients with groundbreaking therapies.


Besides highly competitive compensation and tangible benefits, would you like to have a noticeable impact and enjoy our culture of innovation, trust and teamwork? Do you want to grow in a different kind of company with an enthusiastic, stimulating environment fostered by open communication and a results-driven approach? Then we welcome your application to join our team in the role of Senior International DRA Project Manager, based in Allschwil.



Job Responsibilities

  • Provides regulatory strategy for the international countries (outside the following countries: US, EU, Canada, Japan, Australia, New Zealand and Switzerland)
  • Maintain regulatory knowledge for international countries (new registrations, variations & renewals of marketed products)
  • Liaise and coordinates all documentation, submissions and activities with affiliates / partners for NCE dossiers and life cycle of marketed products
  • Responds to Health Authority questions in coordination with Global DRA Project Leader and project team
  • Applies for the preparation and shipment of registration samples
  • Coordinates the archiving of submitted registration dossiers and other relevant Health Authority communications
  • Evaluates and reviews the regulatory activities of potential and existing business partners contracts and quotations
  • Deputizing the Group Leader, as necessary
  • Opportunity to mentor the Junior International DRA Project Manager

Candidate Requirements

  • Degree in life science and at least 5 years previous experience working in regulatory affairs, preferably with regions outside of the EU and US
  • Good knowledge of international regulatory legislation and guidelines
  • Ability to work in multicultural environment
  • Excellent communication, interpersonal, negotiation and problem solving skills
  • Capable of working independently as well as effective team player
  • Accuracy and good project management skills
  • Excellent command of spoken and written English, other languages are advantage
  • Management experience is an advantage


What Actelion Offers

  • A competitive salary and generous social benefits
  • The possibility for development and advancement within our dynamic organization
  • The innovative and stimulating atmosphere of a multicultural environment


The research facilities are located in Allschwil, Switzerland, a suburb of Basel on the borders of France and Germany.



Primary Location

: CH-BL-Allschwil


: Regulatory Affairs


: Full-time

Job Type

: Standard

Job Posting

: Aug 18, 2016