Global Regulatory Strategist
Vor 3 Tagen
**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.**
**Global Regulatory Strategist M/F/d**
**YOUR TASKS AND RESPONSIBILITIES**
- Represent Oncology Regulatory Affairs on assigned global teams
- Develop and implement regulatory objectives and strategies on a regional and/or global basis (as appropriate) for assigned oncology projects from development through life cycle
- Participate in decision making on all key development questions
- Develop submission materials for local and/or global submission, guide the review process, check for accuracy, scientific consistency, compliance to local and global health authority regulations and completeness of submission
- Lead or participate in a global regulatory team (GRT). This may include coordination of worldwide regulatory input on global development plans for assigned projects
- Lead communications with the regional health authority. Lead preparations for health authority meetings and facilitation of meetings
- Conduct regulatory due diligence on potential in licensing opportunities
**WHO YOU ARE**
- Technical doctorate degree in life sciences, preferred 6 years in medical research activities of which 1-3 years include local/ global regulatory experience in related TA area, or Master of Science degree with 8 years of medical research activities of which 3-5 years include local/global regulatory experience, or Bachelor of Science degree with 10 years of medical research activities of which 5-10 years include local/global regulatory experience
- Expert knowledge of the regional/global health authority regulations, and experience interacting with local health authorities
- Excellent communication skills, verbal and written
- Strong analytical skills
- Demonstrated leadership and project management skills, including cross functional communication, interpersonal and influence management skills
- Ability to discuss and effectively deal with issues such as product safety and drug regulation compliance with internal and external strategic partners
- Fluent in English, both written and spoken
LI-CH
**YOUR APPLICATION**
**Location**:
Switzerland : Basel-City : Basel
**Division**:
Pharmaceuticals
**Reference Code**:
789323
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