Reg Strategist Global Product Expansion

Vor 3 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.**

**Reg Strategist Global Product Expansion**

**Job Purpose**

Responsible for creation and implementation of regulatory strategies and dossiers to support the expansion of Bayer Consumer Health (BCH) products into new markets. Ensures that regulatory dossiers reflect the latest and most appropriate information and that this data is accessible to local regulatory affiliates. Drives assigned products through the registration process, where required, ensuring timely submission. Identifies risks and mitigation plans to achieve first cycle approval.

**Your Tasks & Responsibilities**
- Proactively identify product expansion opportunities that will positively impact the Consumer Health business.
- Develop, align, and implement product regulatory strategies to expand existing BCH products into new markets in close collaboration with GCBU, Product Supply, R &D and other RMSC (Regulatory, Medical, Safety & Compliance) colleagues.
- With mínimal supervision of the Team Lead, manage the timelines and deliverables for preparation of accurate and timely Regulatory Dossiers for complex projects. Accountable for the final content.
- Submit dossiers to global Health Authorities, as required.
- Develop response strategy for requests for additional information, including deficiency letters. Accountable for the final content
- Proactively identify potential regulatory issues and design/execute mitigation plans.
- Represent CH RA Product Expansion on cross functional and regulatory project teams.
- Ensure that all registration data are entered into the proper data management systems
- Track Regulatory activities, and proactively identify issues and risks, alerting management as needed
- Report status measures to the Team Lead and appropriate stakeholders
- With mínimal guidance of Team Lead, may participate in due diligence and Trade Association activities and Health Authority Meetings

**Who you are**
- A degree in the life sciences (post-graduate degree is preferred but not required).
- At least 6 years relevant RA experience (including experience with OTC medicinal products).
- Knowledge of European and International Consumer Product legislation, including medicinal products
- Experience conducting European Regulatory Procedures (Decentralized, Mutual Recognition & National)
- Demonstrated ability to articulate and formulate solutions for complex regulatory issues
- Knowledge / experience in project management
- Proficiency in MS Office: Word, Excel, PowerPoint
- Ability to grow in leadership capabilities
- Ability to communicate effectively in English both verbally and in writing
- Ability to work as a member of a team
- Results oriented

**YOUR APPLICATION**

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

**Division**:
Consumer Health

**Reference Code**:
696835



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