Role Overview for VP, Global Regulatory CMC with a Biologics Manufacturer – Philadelphia, PA
JRG Partners is proud to partner with a pioneering, research-driven biologics manufacturer at the forefront of developing life-saving therapies. Located in the vibrant biopharmaceutical hub of Philadelphia, PA, our client is seeking a visionary and strategic leader to join their executive team as the Vice President, Global Regulatory CMC. This is a paramount role responsible for providing leadership and direction for all Chemistry, Manufacturing, and Controls (CMC) regulatory activities across the company’s diverse and growing portfolio of biologic products.
The VP, Global Regulatory CMC will be the organization’s foremost expert on the global CMC regulatory landscape. This individual will build, lead, and inspire a high-performing team dedicated to developing and executing innovative and effective regulatory strategies. This executive will ensure that all CMC submissions are of the highest quality, enabling expedited development timelines and successful product approvals worldwide. The successful candidate will be a key member of the senior leadership team, collaborating cross-functionally to align regulatory strategy with corporate objectives and ensure seamless integration of CMC considerations from early-stage development through to commercialization and lifecycle management.
This is a unique opportunity to shape the regulatory future of a dynamic organization and make a tangible impact on patient lives globally. If you are a seasoned regulatory affairs leader with deep expertise in biologics and a passion for driving scientific innovation, we invite you to explore this career-defining role.
Key Responsibilities of VP, Global Regulatory CMC with a Biologics Manufacturer – Philadelphia, PA
The Vice President, Global Regulatory CMC will be entrusted with a broad range of critical responsibilities, including but not limited to:
Strategic Leadership & Vision
Develop, articulate, and execute comprehensive global regulatory strategies for CMC across the entire product lifecycle, from pre-clinical development through post-approval changes. Provide strategic guidance to project teams and senior management on CMC regulatory pathways, risks, and mitigation strategies for complex biologic products.
Global Submissions Oversight
Lead the planning, preparation, review, and timely submission of high-quality CMC sections for all global regulatory filings. This includes Investigational New Drug applications (INDs), Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), Marketing Authorisation Applications (MAAs), and all post-approval supplements and variations.
Health Authority Engagement
Serve as the primary senior liaison with global health authorities (e.g., FDA, EMA, Health Canada, PMDA) for all CMC-related discussions, negotiations, and meetings. Proactively build and maintain strong, positive relationships with regulatory agencies. Prepare teams and lead strategy for critical health authority interactions.
Team Development & Mentorship
Recruit, lead, mentor, and develop a world-class global Regulatory CMC team. Foster a culture of scientific excellence, collaboration, accountability, and continuous improvement. Provide ongoing coaching and create development opportunities to ensure team growth and success.
Cross-Functional Collaboration
Act as a strategic partner to leaders in Technical Operations, Manufacturing, Process Development, Quality Assurance, and Clinical Development. Ensure tight integration and alignment of CMC activities with overall program goals and timelines. Provide expert regulatory input to resolve complex manufacturing and quality challenges.
Regulatory Intelligence & Policy
Continuously monitor, analyze, and interpret the evolving global regulatory landscape for biologics CMC. Proactively assess the impact of new regulations, guidance documents, and industry trends on the company’s portfolio and development programs. Influence and contribute to shaping regulatory policy where possible.
Due Diligence & Business Development
Provide critical CMC regulatory expertise and leadership for due diligence assessments of potential in-licensing, acquisition, and partnership opportunities. Evaluate the regulatory risks and opportunities associated with external assets.
Process Excellence & Compliance
Establish and maintain best-in-class processes, systems, and standard operating procedures (SOPs) for the Regulatory CMC function. Ensure all activities are conducted in full compliance with cGMP and global regulatory requirements. Drive operational excellence and efficiency within the department.
Budget & Resource Management
Develop and manage the annual departmental budget, ensuring optimal allocation of financial and human resources to meet strategic objectives and program milestones.
Requirements for the VP, Global Regulatory CMC with a Biologics Manufacturer – Philadelphia, PA
The ideal candidate will possess a unique blend of scientific expertise, strategic acumen, and leadership gravitas. The following qualifications are essential for success in this role:
Educational Background
An advanced degree (MS, PhD, or PharmD) in a relevant life sciences discipline such as Biotechnology, Chemistry, Pharmaceutical Sciences, or a related field is required.
Professional Experience
A minimum of 15+ years of progressive experience within the biopharmaceutical industry, with at least 10 years dedicated to Regulatory Affairs CMC. A significant portion of this experience must be in a leadership capacity, managing teams and strategy.
Biologics Expertise
Deep and extensive hands-on experience with the development and registration of biologic products is mandatory. This includes monoclonal antibodies, recombinant proteins, vaccines, and/or advanced modalities such as cell and gene therapies.
Global Regulatory Acumen
Demonstrated success in leading the preparation and submission of major marketing applications (BLA/MAA) and interacting directly with major global health authorities, including the FDA and EMA. A proven track record of successful regulatory outcomes is essential.
Leadership & Influence
Exceptional leadership skills with the proven ability to build, manage, and motivate a high-performing global team. Must possess strong interpersonal, communication, and presentation skills, with the ability to influence and align stakeholders at all levels of the organization.
Strategic Thinking
A highly strategic and analytical thinker who can navigate complex and ambiguous regulatory environments. The ability to translate regulatory requirements into practical, workable strategies is critical.
Technical Knowledge
Strong understanding of biologic manufacturing processes, process validation, analytical method development and validation, stability studies, and cGMP principles.
Problem-Solving Skills
Excellent judgment and creative problem-solving skills, with the ability to make sound decisions based on a balanced assessment of science, risk, and business needs.
Benefits & Perks Offered
Our client believes that their employees are their most valuable asset and is committed to providing a comprehensive and competitive benefits package to support their health, well-being, and financial security. This includes:
Competitive Compensation
A highly attractive base salary, significant annual performance-based bonus, and a meaningful long-term equity/stock option package.
Comprehensive Health & Wellness
Premium medical, dental, and vision insurance plans with low employee contributions. Access to wellness programs, mental health resources, and a generous fitness reimbursement.
Retirement Savings
A robust 401(k) plan featuring a generous company match to help you plan for your future.
Work-Life Balance
A generous paid time off (PTO) policy, numerous paid company holidays, and comprehensive parental leave programs.
Professional Growth
A strong commitment to employee development, with a dedicated budget for attending conferences, pursuing certifications, and other professional development opportunities.
Relocation Support
A comprehensive relocation package is available for qualified candidates moving to the Philadelphia area.
Inspiring Culture
The opportunity to work in a collaborative, mission-driven, and innovative environment with brilliant colleagues dedicated to making a difference in medicine.
How to Apply
JRG Partners is the exclusive search firm retained for this critical executive leadership position. If you are a qualified and passionate regulatory leader who meets the above criteria and is ready to take on a new challenge, we encourage you to apply.
To be considered for this opportunity, please submit your resume and a cover letter detailing your relevant experience. For more information about our expertise in this sector, please visit our Life Sciences and Pharmaceuticals Practice Area page. We look forward to connecting with you.
Our client is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
