Global Regulatory Leader in Vitro Diagnostics

vor 3 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 Leader In Vitro Diagnostics M/F/d**

**YOUR TASKS AND RESPONSIBILITIES**

Acts as Bayer’s regulatory strategy lead in drug

Main tasks:

- Coordinate regulatory consultancy input into IVD/CDx regulatory strategies
- Provide IVD/CDx regulatory input to multiple development projects:

- Advise GRSs on individual IVD/CDx regulatory strategies as part of the broader project regulatory strategy
- Contribute to CDx TPP development
- Provide IVD/CDx regulatory advice to Early Development Project Leaders / Biomarker Project Leaders / Early Clinical Leaders and the respective late development roles
- Provide specialist IVD/CDx input and reports to early and late GPTs
- Preparation and leadership of dialogue with HA representatives to support the acceptance of the IVD/CDx strategy
- Manage multiple IVD/CDx development partnerships:

- Provide regulatory feedback on partnership contracts
- Build and maintain relationships with regulatory colleagues from the CDx partner companies
- Substitute for Regulatory representative on Joint Collaboration Committees, as needed
- Participate in project review meetings
- Propose ideas to facilitate improved collaboration
- Responses to HA and EC questions related to diagnostic testing
- Ensure partner IVD/CDx labeling, and Instructions for Use is consistent with Bayer target labeling
- Contribute to internal regulatory IVD/CDx expertise development
- Develop and share Bayer Case Studies Design, prepare and implement training programs
- Monitor key changes in the global regulatory environment in the area of personalized medicine, with special focus on diagnostic tests relevant for cell and gene therapy
- Build the internal and external network; represent Bayer in relevant industry associations
- Monitor and contribute to guidance in key regions including US and Europe, Japan and China
- Provide regular updates to all GRSs and other stakeholders / internal groups
- Identify priority areas and provide input to Regulatory Policy

**WHO YOU ARE**
- Advanced technical degree (Ph.D., DVM, MD or Pharm D) in biological, chemistry, or related sciences preferred with extensive experience in biomarker/IVD/ regulatory affairs / drug-related development / medical research activities
- MS degree with long term of biomarker/IVD / regulatory affairs / drug
- related development / medical research activities or BS degree with long term of biomarker/IVD / drug-related development / medical research activities.
- Several years of research experience in Biomarker/IVD strategy development.
- Working knowledge of US, EU, and international medical device (regulatory requirements; demonstrated experience with health authority interactions and submissions; Good knowledge of registration files for Medical Devices and/or In Vitro Diagnostics
- Solid experience leading regulatory submissions for IVD/CDx, including for use in drug clinical trials.
- Experience in cell and gene therapy
- Familiarity with regulatory issues and challenges associated with Drug/Diagnostic co-development
- Good understanding of IVD development process is required, recent experience with IVD/drug co
- development projects and understanding of drug development process for cell and gene therapy
- Ability to knowledgeably discuss and effectively deal with issues such as product safety and drug/device regulation and compliance with internal and external strategic partners
- Fluency in the English language
- Excellent communication skills, verbal and written, and ability to effectively communicate with cross-functional teams
- Strong analytical skills are required; ability to find effective solutions for varied and complex problems
- Demonstrated leadership and project management skills, working across cultures, interpersonal and influence-management skills

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**:793580

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