Senior Principal Scientist, Regulatory Liaison (Sr. Director, GRL)

$181,600 - $285,800/Yr

Merck KGaA Darmstadt Germany - North Wales, PA

Full-time - Senior

Onsite - North Wales, PA

Chemical Manufacturing

About the position

The Senior Principal Scientist | Regulatory Affairs Liaison is responsible for developing and implementing worldwide regulatory strategies for projects in the General Medicine therapeutic area, particularly in Immunology, Neuroscience, and Ophthalmology. This role involves managing complex projects independently, providing regulatory oversight, and ensuring optimal product labeling to achieve the shortest time to approval by global regulatory agencies. The individual will serve as the primary global contact for regulatory strategy and registration requirements, coordinating submissions and approvals with regulatory agencies.

Responsibilities

• Develop worldwide product regulatory strategies to optimize labeling and obtain the shortest time to approval by regulatory agencies for multiple indications simultaneously.
• Assess regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and targeted product labeling.
• Provide expert advice as the Global Regulatory Lead to Product Development Teams and serve as the regulatory single point-of-contact for products.
• Lead the Global Regulatory Team to coordinate cross-functional regulatory support for development programs and marketed products.
• Review and approve local registration study protocols to obtain marketing authorization in secondary markets.
• Represent the company with external organizations through direct communication with the FDA and chair meetings between the company and FDA.
• Coordinate interactions with foreign agencies to support their interactions and provide strategic direction across multiple regions.
• Review and approve Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release to external agencies.
• Conduct initial IND/CSA content review and approval to facilitate initial approval by agencies for clinical trials.
• Participate in regulatory due diligence activities for licensing candidate review.

Requirements

• B.S. or M.S. with a minimum of 10 years of relevant drug development experience, primarily in regulatory, or M.D. or PhD/PharmD with a minimum of 7 years relevant drug development experience with five years in regulatory.
• Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead.
• Skilled in assessing global regulatory/competitive landscape to establish global regulatory strategies that facilitate speed to market while delivering targeted product labeling.
• Strong verbal and written communication skills.

Nice-to-haves

• Substantial experience with immunology, neuroscience, and/or ophthalmology development programs.
• Experience with small and large molecules.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits for employee and family
• Retirement benefits
• Paid holidays
• Vacation
• Sick days