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.
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.
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
Job: Clinical Development
Job Type: Standard
Job Posting: Sep 19, 2016