Principal Scientist, (Director) - Regulatory Liaison

Job Description

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 provide regulatory oversight for assigned products in order to optimize product labeling and obtain 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.

Coordinate the preparation, submission, and any follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions and be responsible for regulatory review and final approval for all submissions and associated documentation. Provide expertise as the Global Regulatory Lead to Product Development Teams and the regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

Key functions:

• Reports to Senior Principal Scientist (Senior Director) and/or Distinguished Scientist (Executive Director)

• Works Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

• Develops 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 with the developmental compounds or marketed products throughout the entire life cycle of the drug

• Provide leadership to the 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

• Represents our Company with external organizations through direct communication with the FDA, including telephone calls and e-mail; 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 to support their interactions and provide strategic direction across multiple regions simultaneously

• Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our Company to external agencies and investigators

• Represent GRA within our Company's internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and Label Evaluation and Development team

• Conducts 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

Minimum Education & Experience 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

Required Experience:

• Ability to achieve optimal results with limited day-to-day direction from Therapeutic Area Lead

Preferred Experience:

• Experience with immunology, neuroscience and/or ophthalmology development programs 

• Small and large molecule experience

• Substantial experience in Regulatory Affairs