Director, Global Regulatory Strategist, CGT Combination Products

Bayer (Schweiz) AG; New Jersey; On-site; USD 120,000 - 180,000; Full time

Job summary

Join a forward-thinking company as a Director, Global Regulatory Strategist, focusing on Cell and Gene Therapy Combination Products. This role involves developing innovative regulatory strategies to achieve global registration and working collaboratively with cross-functional teams. If you are passionate about making a meaningful impact in healthcare and possess expertise in regulatory affairs, this opportunity is perfect for you. Be part of a diverse team dedicated to solving complex challenges and advancing health solutions worldwide. Your leadership and strategic insights will be crucial in navigating the regulatory landscape and driving successful product approvals.

Benefits

Competitive compensation

Health care plans

Flexible working conditions

Career development opportunities

Qualifications

• Expert knowledge of global medical device regulations and combination products.
• Strong leadership and project management skills required.

Responsibilities

• Develop and implement global regulatory strategies for combination products.
• Lead and participate in regulatory affairs teams for new product development.

Skills

Regulatory Strategy Development

Communication Skills

Project Management

Analytical Skills

Negotiation Skills

Education

BS degree

Advanced scientific degree (PhD)

MS degree

Tools

FDA Quality System Regulations

ISO 13485

EU MDR

Job description

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.

Director, Global Regulatory Strategist, CGT Combination Products

The Director, Global Regulatory Strategist, Cell & Gene Therapy (CGT) Combination Products requires a Global Regulatory Expert who can lead Combination Product Asset Development projects to achieve global registration. The position will work within a team of Global Regulatory Strategists who have regional/local responsibility for their assigned programs.

YOUR TASKS AND RESPONSIBILITIES

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

1. Develop and implement robust global Regulatory strategies for complex/high impact programs for Combination Products in Bayer’s portfolio including Cell and Gene Therapies (CGT) that leverage regulations in the US, EU and other target markets, and employ innovative approaches that enable fastest path to first cycle approval (e.g., core dossiers, IND, CTA, BLA, MAA, Technical Files, etc.);
2. Lead and/or participate in key new product development Regulatory Affairs Teams and/or Global Project Teams; effectively collaborate with Bayer’s functions involved in combination product development to advance the assigned programs;
3. Serve as the Global Regulatory Expert for the assigned programs and partner effectively with CMC, Product Supply (Medical Devices), Radiology, Therapeutic Areas & Labeling, and Bayer’s CGT subsidiaries (as applicable), to develop strategy documents to support decision making at Governance committees and for formal meetings with Health Authorities;
4. Understand and communicate scientific principles and regulatory requirements relevant to global drug-device combination product development;
5. Provide global regulatory assessments for requirements of drug-device combination products according to existing global guidelines and policies;
6. Lead preparations and follow-up for project meetings and teleconferences with US/Can/EU health authority officials and aid in other country health authority meeting processes.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

1. A minimum of a BS degree is required;
2. Expert knowledge of regional and global medical device regulations (e.g., EU MDR, Declarations of Conformity, CE Marking, ISO 13485, FDA Quality System Regulations, Design Control, 510(k), PMA etc.), particularly as they pertain to development of combination products; demonstrated interactions with local and global health authorities and notified bodies;
3. Direct experience in developing regulatory strategies, creation of regulatory submission files obtaining FDA or EU clearance/approvals for combination products is required;
4. Strong ability to communicate and negotiate effectively in English both verbally and in writing, and strong analytical skills are required;
5. Demonstrated leadership and project management skills, including cross-functional communication, interpersonal and influence-management skills, and collaboration skills;
6. A clear understanding of cultural and business needs in leading a diverse team.

Preferred Qualifications:

1. Advanced scientific degree (e.g., PhD) in Biomedical Engineering, Pharmacology, Healthcare, or related discipline preferred, with 6 years of experience with local/global regulatory submissions for combination products or a MS degree in Biomedical Engineering, Pharmacology, Healthcare, or related discipline with 8 years of experience with local/global regulatory submissions for combination products;
2. Experience with regulatory activities for cell and gene therapies or digital technologies (wearable devices, etc.) is preferred.

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

#LI-US

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

Division: Pharmaceuticals

Reference Code: 842231

Contact Us

Email: [e-mail]