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Associate Director, Regulatory Affairs - Switzerland
Posted on : 07 May 2017
- The Associate Director, Regulatory Affairs is responsible for actively leading the development and implementation of regulatory strategy, serving as the global or European regulatory representative on relevant project teams. The Associate Director, Regulatory Affairs will be responsible for leading, managing and executing activities for the development and registration of new products in all regions.
- This challenging role will be key for the achievement of mid to long term corporate objectives and in particular to identify fast track access to get products to patients in need, as early as possible.
In the context of assigned projects, the Associate Director, Regulatory Affairs will:
- Be responsible for identifying global regulatory strategies and for actively leading their implementation, including evaluation of scientific data, extensive review of existing guidelines, assessment of regulatory trends and identification of fast track options for registration
- Be responsible for identifying tactics to achieve earliest possible approvals of all regulatory submissions for orphan products
- Be responsible for coordinating all aspects of regulatory submissions for development activities including but not limited to clinical trials submission (CTA), scientific advice, orphan drugs designation, pediatric investigation plan (PIP)
- Represent regulatory function as global or European lead to facilitate the achievement of corporate objectives
- Develop regulatory and competitive intelligence to support the formulation of efficient and effective regulatory strategy with international scope
- Identify, assess regulatory risks and propose mitigation strategies
- Be the main contact with regulatory agencies
- Potentially supervise regulatory professionals or trainees
- Ability to drive teams towards making adequate and timely decisions
- Ability to reach objectives through leading cross-functional team work
- Ability to convey key messages in efficient oral presentations
- Excellent time management and priority-setting skills
- Proven excellent diplomacy skills
- M.S, Pharm. D. or Ph.D. in biochemistry, chemistry, biology or related pharmaceutical field, with 8 year experience in regulatory affairs
- Experience in Pharmaceutical or Biotechnology industry in development and registration of biotechnological products, and in particular in the development of orphan products
- Record of successful development and registration submissions
- Knowledge of EU pharmaceutical regulations and related ethic behaviors
- Fluent in English both spoken and written
- Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.
- As the global leader in complement inhibition, our company is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.
- Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders
- In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.