Director, Regulatory Affairs, CMC (Biologics)
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
Merck is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Merck Research Laboratories is a true scientific research facility of tomorrow, and will take Merck’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
Reporting to the Executive Director Biologics, CMC, the Director will provide regulatory leadership, oversight and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions for biologics. This includes preparation of applicable sections of clinical applications (IND and IMPD), Agency Background Packages, Worldwide Marketing Applications (for Most of World applications), and responses to Agency questions for global markets. The primary focus of the position is providing direction to team members responsible for developing and executing implementation of regulatory strategies, and making decisions that ensure the high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during various phases of development, defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence and incorporating knowledge of the changing regulatory environment. The individual will establish and oversee the regulatory CMC team at. This individual will be responsible to hire, mentor and coach the team to support development activities in the biologics portfolio. This individual will also develop expertise and educate the team on the nuances of new technology implementation, regulatory challenges and collaborate with the development team to develop innovative regulatory approaches that facilitate the implementation of the technologies in early stage with an eye towards commercialization.
The Director responsibilities include but are not limited to:
- Accountable for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner.
- Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges.
- Drive application of regulatory strategies and concepts across multiple disciplines and multiple organizations.
- Embody the Merck Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.
- Continuously evaluate and develop talent within the team and prepare a succession plan.
- Use recognition and rewards to promote team and organizational collaboration.
- Hold employees accountable for execution of departmental policies and procedures.
- Flexibly manage and allocate resources within area to support execution and delivery of prioritized work to meet business commitments.
- Actively sponsor employees who lead and participate in Merck initiatives.
- Cultivate and foster strong collaborative relationships with stakeholders and partners across the organization.
- Represent the department’s needs and positions in senior leadership forums.
- Occasional travel to manufacturing sites may be required.
- Required:B.S. in biological sciences, biochemical engineering, or a related discipline.
- Preferred: Advanced degree with a concentration in Microbiology, Virology, Molecular Biology, Engineering or Biochemistry
- Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree.
- Minimum 5 years working in Regulatory CMC, including the development stages of the product life cycle, and minimum 3 years managing people.
- Industrial/regulatory experience in biologics research, development and/or manufacturing
- Prior Biologics License Application (BLA) or Investigational New Drug (IND) experience
- Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data.
- Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
- Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
- Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
- Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
- The ideal candidate will have strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance) and experience managing a team of Regulatory CMC professionals.
- A candidate with strong experience in Biologics pre/post approval expertise is highly preferred.
- The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
- He/she must have a depth of experience in defining global Regulatory CMC strategy, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.
- The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.
- The candidate must have demonstrated experience in building, rewarding and retaining key talent. He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. The candidate must be proficient in English; additional language skills are a plus.
Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. If you need an accommodation for the application process please email us at email@example.com.
Search Firm Representatives Please Read Carefully:
Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.
For more information about personal rights under Equal Employment Opportunity, visit:
Job: Regulatory Affairs - CMC
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings:
Shift (if applicable):
Company Trade Name: Merck