Senior Director Global Regulatory Strategist, CGT

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Senior Director Global Regulatory Strategist, CGT

The Senior Director Global Regulatory Strategist, Cell and Gene Therapy (CGT) requires a Senior Global Regulatory Expert who can lead complex CGT Development projects to achieve global registration. The position will lead the Global Regulatory Team for complex/high priority programs, including a team of Global Regulatory Strategists who have regional/local responsibility for the assigned program.

Your Tasks And Responsibilities

The primary responsibilities of this role, Senior Director Global Regulatory Strategist, CGT, are to:

• Have accountability for developing robust Global Regulatory Strategy for complex/high impact CGT programs in the R&D portfolio that leverages accelerated regulatory approval pathways and other innovative strategies that enable fastest path to first cycle approval;
• Provide guidance and oversight to Global Regulatory Strategists on assigned program that have regional and/or local responsibility to ensure integration of regional/local requirements into the overall Global Regulatory Strategy;
• Serve as the Global Regulatory Expert for the assigned program and partners effectively with the Head of Clinical Development Therapeutic Area, Global Program Head, Global Clinical Leader (GCL)/Early Clinical Leader (ECL), Global Project Leader (GPL)/Early Project Leader (EPL) and the Biomarker Leader to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities;
• Effectively collaborate with Bayer’s Cell and Gene Therapy (CGT) subsidiary companies to advance co-development programs.
  
  

Who You Are

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• A minimum of a BS degree in life sciences is required;
• Medical Research activities including local/global regulatory experience in the Cell & Gene Therapy (CGT);
• Expert knowledge of the regional and global regulations, particularly as they pertain to development of CGT products; demonstrated interactions with local and global 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;
• A clear understanding of cultural and business needs in leading a diverse team.
  
  

Preferred Qualifications:

• Advanced technical degree, Ph.D. in molecular biology or related discipline preferred, with 8 years in medical research activities of which 3-5 years include local/ global regulatory experience in CGT area, or MS degree in molecular biology or related discipline with 10 years of medical research activities of which 5-7 years include local/global regulatory experience with 3-5 years in the CGT area.
  
  

This posting will be available for application until at least: 4/8/25.

YOUR APPLICATION

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and want to impact our mission Science for a better life, we encourage you to apply now. Be part of something bigger. Be you. Be Bayer.

To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Bayer is an E-Verify Employer.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Location: United States : New Jersey : Whippany || United States : Massachusetts : Cambridge

Division: Pharmaceuticals

Reference Code: 842131

Contact Us

Email: hrop_usa@bayer.com