Liaison Global Regulatory Strategy Integration

Vor 4 Tagen

Basel, Schweiz Bayer Vollzeit

**At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.**

**Liaison Global Regulatory Strategy Integration M/F/d**

**YOUR TASKS AND RESPONSIBILITIES**
- Develops Regulatory Strategy for assigned projects and countries by designing and assessing regulatory strategy options on a regional/global basis (as outlined in the Global Regulatory Plan) in collaboration with local/regional regulatory teams.
- Actively involved in decision making on all key development questions via an assessment on the probability of regulatory success.
- Develops the regional/global regulatory project goals from development through life cycle.
- Member of the Global Regulatory Team.
- Develops submission materials for local and global submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global HA regulations and completeness of submission.
- Coordinate worldwide regulatory input into the global development plan of assigned projects.
- Organizes and drives preparations for meetings and teleconferences with local and global HA officials.
- Conduct regulatory due diligence on potential in-licensing opportunities.
- Interacts with the local regulatory team in China, Japan, India as well as other ex-US and ex-EU countries to support the conduct of Oncology Clinical Trials, the development of Clinical Trial infrastructure for Precision Medicine and registration of Oncology drugs and diagnostics.
- Serve as the Liaison between the global regulatory teams and the local regulatory and development teams to support effective interactions with local Health Authorities and to enable registration of Oncology drugs and diagnostics in the shortest time possible. The main objectives are to contribute, align and to execute regulatory strategies for assigned projects in. China, Japan, India as well as other ex-US and ex-EU countries.

**WHO YOU ARE**
- Advanced technical degree Ph.D., DVM or Pharm D in life sciences with 6 years direct experience in biomedical research, of which 1-3 years include local/global regulatory experience in related TA area; or MS degree with 8 years of experience in biomedical activities of which 3-5 years include local/global regulatory experience; or BS degree with 10 years of experience in biomedical activities of which 5-10 years include local/global regulatory experience.
- Expert knowledge of the regional HA regulations and advanced knowledge of global regulations. Demonstrated interactions with local health authorities.
- Excellent communication skills, verbal and written, and strong analytical skills are required.
- Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills.
- Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners.
- Experience working with clinical research and/or regulatory teams based in one or more ex-US/ex-EU countries, e.g. China, Japan, India, Brazil, Korea, Singapore, Taiwan and other countries.

LI-CH

**YOUR APPLICATION**

**Location**:
Switzerland : Basel-City : Basel

**Division**:
Pharmaceuticals

**Reference Code**:
582502

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