Global Regulatory Strategist in Vitro Diagnostics

vor 7 Monaten

Berlin, Deutschland 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.**

**Global Regulatory Strategist In Vitro Diagnostics**

**YOUR TASKS AND RESPONSIBILITIES**

The position is responsible for the development, alignment, and implementation of drug and diagnostic regulatory strategies to ensure earliest submissions and first cycle approvals with target labels for the biomarker driven projects on a global basis. Further, the position is in charge for assessing and aligning the probabilities for regulatory success for the assigned development projects.

Main tasks:

- Develops Regulatory Strategy for in vitro diagnostics (IVD) and companion diagnostics (CDx) by designing and assessing regulatory strategy options on a regional/global basis. Ensures global regulatory plans support a precision medicine approach (e.g., integrated drug/diagnostic regulatory and submission plans), including HA engagement plans and mitigation strategies
- Actively involved in decision making on all key development questions via an assessment on the probability of IVD regulatory success.
- Develops the regional/global regulatory project goals from development through life cycle management.
- Represents Global Regulatory Affairs on assigned global IVD Project Teams.
- Develops submission materials for local and global IVD submission, guides the review process, checks for accuracy, scientific consistency, compliance to local and global in vitro diagnostics regulations and completeness of IVD submission.
- Leads a global regulatory team (GRT) and coordinates worldwide regulatory input into the global development plan of assigned IVD projects.
- Organizes and drives preparations for meetings and teleconferences with local and global IVD HA officials.
- Conducts regulatory IVD due diligence on potential partnership opportunities.

**WHO YOU ARE**
- Advanced technical degree (Ph.D., DVM or PharmD) in biological, chemistry, or related sciences with several years or more direct experience in pharmaceutical/device development, of which moderate local/global regulatory IVD experience; or MS degree in life sciences with extensive years or more of experience in pharmaceutical/device development of which several years include local/global IVD regulatory experience; or BS degree in life sciences with long term experience in pharmaceutical/device development of which several years include local/global regulatory IVD experience.
- Solid experience in leading or supporting regulatory submissions for IVD/CDx, including for use in clinical trials.
- Expert knowledge of the regional biomarker/IVD regulations and advanced knowledge of global IVD 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/device regulation compliance with internal and external strategic partners

LI-GH

**YOUR APPLICATION**

This is your opportunity to tackle the world’s biggest challenges with us: Maintaining our health, feeding growing populations and slowing the rate of climate change. You have a voice, ideas and perspectives and we want to hear them. Because our success begins with you. Be part of something big. Be Bayer.

**Location**: Germany : Berlin : Berlin

**Division**: Pharmaceuticals

**Reference Code**:793579

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