38 days ago on jobs.actelion.com

Global DRA Project Leader

Actelion Pharma Schweiz AG

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Global DRA Project Leader

Global DRA Project Leader - (160000HK)


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 Global DRA Project Leader, based in Allschwil.



Job Responsibilities


The global drug regulatory affairs (DRA) project leader participates in or leads the full range of regulatory activities for both development projects and marketed product projects at the global level.

  • Define and provide optimal global regulatory strategies to support the development and approval of new drugs as well as product life-cycle management activities for assigned product(s)
  • Lead creation of regulatory function plans, including identification and critical assessment of regulatory issues
  • Provide consolidated interpretation of relevant Health Authority regulatory guidelines for the development and approval of new drugs as well as product life-cycle management
  • Lead the global submission planning process, creation, review and finalization of key regulatory documents intended for submission to HAs
    Represent DRA in lifecycle-, CT- other project related meetings, management committees and governance related meetings
  • Lead creation, review, finalization and maintenance of CCDS for assigned products including communication of changes (with supporting documentation) to affiliates for implementation
  • Establish and lead regulatory sub-teams at relevant points in development with communication of plans and updates on a regular basis
  • Ensure communication and regulatory support for other countries (ex US) in collaboration with the international DRA project manager, affiliate and regulatory operations, as needed
  • Collaborate closely with the US based DRA partner for regulatory considerations, strategy and key regulatory document
  • Ensure DRA project milestones are achieved
  • Conduct critical review of all global promotional material prior to country specific review.

Candidate Requirements

  • Minimum bachelor’s degree level education in a scientific subject. Preference for candidates educated to master’s degree level of education or higher
  • At least 5 years’ experience of regulatory affairs for medicinal products working at the European or global level
  • Good knowledge of regulatory legislation and guidelines (ICH and EU) and major global regulatory systems
  • In depth knowledge and experience with EMA and EU NCA’s. Experience with various types of EU submissions
  • Good understanding of the regulatory aspects at various stages of development, from entry-into man to post approval activities
  • Experience working and communicating with the EMA/EU NCA’s, including coordinating and managing meetings for scientific advice
  • Familiarity with clinical trial methodology and statistics
  • Excellent communication, interpersonal, negotiation and problem solving skills
  • Organizational awareness (e.g. understands interrelationships between functions, departments and business priorities)
  • Effective team player, with experience working in cross-functional and global teams, but also able to work independently
  • Ability to work within tight timelines with excellent project management skills.


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


: Clinical Development


: Full-time

Job Type

: Standard

Job Posting

: Sep 19, 2016