Principal Scientist, (Director) - Regulatory Liaison

Merck & Co. • North Wales, PA

229d • $169,700 - $267,200 • Onsite

About The Position

The Director/Principal Scientist, Regulatory Affairs Liaison, is responsible for the development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine therapeutic area with a specific focus on development programs in Ophthalmology. The individual functions with a degree of independence and provides regulatory oversight for assigned products in order to optimize product labeling and obtain the shortest time to approval by regulatory agencies. You will independently manage projects, functioning as the single, accountable, global point of contact on those projects and interact independently with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our company investigational and marketed drugs/biologics. Programs may be complex with more than one indication, formulation or have an external business partner.

Requirements

• Degree in biological science or related discipline.
• B.S. with minimum of 7 years of relevant drug development experience.
• M.S. with minimum of 5 years relevant drug development experience.
• M.D. with minimum of 3 years relevant drug development experience or clinical experience.
• PhD/PharmD with minimum of 5 years relevant drug development experience.

Nice To Haves

• Experience with immunology, neuroscience and/or ophthalmology development programs.
• Small and large molecule experience.
• Substantial experience in Regulatory Affairs.

Responsibilities

• Develop worldwide product regulatory strategy to optimize product labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.
• Provide expert advice as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within and external to GRACS on regulatory issues as they arise.
• Lead 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.
• Prepare our Company's teams for meetings with FDA at any phase of drug development.
• Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.
• Coordinate interactions with foreign agencies through Regulatory Affairs Europe and the subsidiary registration departments.
• Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release.
• 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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree