Director (Principal Scientist), Regulatory Liaison - Oncology
Merck
Summary
The Global Regulatory Liaison is responsible for development and implementation of worldwide regulatory strategy for assigned projects in the Oncology, Immunology and Devices therapeutic area. The candidate will provide regulatory oversight for assigned products to optimize label and obtain shortest time to approval by regulatory agencies, independently managing projects as the single accountable global point of contact.
Job description
Primary Responsibilities
- Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
- Provide expert advice to Product Development Teams and subsidiaries on regulatory issues throughout the entire life cycle of the drug.
- Provide direction to staff by leading the Global Regulatory Team which coordinates cross-functional regulatory support for development programs and marketed products.
- Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
- Represent the company with external organizations through direct communication with the FDA, chair meetings between company and FDA, and prepare teams for FDA meetings at any phase of drug development.
- Lead cross-functional efforts to prepare for advisory committees.
- Coordinate interactions with foreign agencies through Regulatory Affairs Europe and subsidiary registration departments to provide strategic direction across multiple regions.
- Review and provide final approval of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release to external stakeholders.
- Represent GRA within internal committees (DRC, PDT, EDT, LEAD) to provide regulatory advice and approval.
- Conduct initial IND/CSA content review and approval to facilitate initial approval by agencies for conduct of clinical trials.
- Participate in regulatory due diligence activities for licensing candidate review.
Education Minimum Requirements
- B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs.
- M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs.
- PhD with minimum of 7 years relevant experience.
- M.D. with minimum of 5 years relevant experience.
Required Experience and Skills
- Ability to achieve optimal results with limited day-to-day direction.
- Ability to think strategically and continuously learn and apply new knowledge.
- Ability to lead, influence, and negotiate.
- Led or directly supported meetings with FDA, EMA, or other Health Authorities.
- Led or directly supported regulatory filings.
- Proactive, clear and effective verbal and written communicator.
Preferred Experience and Skills
- Oncology experience.
- Immunology and biologics experience.
- Substantial experience in regulatory affairs in at least one major country/region (e.g., U.S.A., European Union, Japan, China).
Requirements
- B.S. Degree in biological science, chemistry or related discipline with minimum of 10 years drug development or clinical experience or regulatory affairs
- M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs
- PhD with minimum of 7 years relevant experience
- M.D. with minimum of 5 years relevant experience
- Ability to achieve optimal results with limited day-to-day direction
- Ability to think strategically and continuously learn and apply new knowledge
- Ability to lead, influence, and negotiate
- Led or directly supported meetings with FDA, EMA, or other Health Authorities
- Led or directly supported regulatory filings
- Proactive, clear and effective verbal and written communicator
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate Leave
- Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.