Director, Global Regulatory Affairs Liaison, Principal Scientist

Job Description

We are seeking a Director (Principal Scientist), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance our pipeline and drive our strategic priorities.

The Director, Principal Scientist | Regulatory Affairs Liaison is responsible for 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 Immunology, Neuroscience and/or Ophthalmology. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, to optimize product labeling and obtain shortest time to approval by global regulatory agencies.

• Reports to Associate Vice President, Executive Director, or Senior Director in the General Medicine Therapeutic Area.

• Independently manages projects within the General Medicine Therapeutic Area, with a focus on Immunology, Neuroscience and/or Ophthalmology, functioning as the single, accountable, global point of contact on those projects.

• Develops global regulatory strategy for their assigned products, to optimize labeling and obtain shortest time to approval by regulatory agencies.

• Functions as global regulatory lead assigned to programs where the compound is first-in-class or is in a new therapeutic area for our company; where no regulatory guidance exists; where the program is accelerated; has an external business partner; there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance.

• Assesses regulatory/competitive landscape to establish global regulatory strategies that facilitate speed-to-market and the delivery of targeted product labeling

• Independently interacts with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's investigational and marketed drugs.

• Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.

• Responsible for regulatory review and final approval of all submissions and associated documentation.

• Provides expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

• Provides leadership to 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.

• Coordinates interactions with foreign agencies through Regulatory Affairs Europe (RAE), Regulatory Affairs International (RAI), and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.                           

• Reviews and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external agencies and investigators.

• Provides expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.

• Represents GRACS within our company's internal committees to provide regulatory advice and approval according to the committee charters. (Therapeutic area document review committees (DRC), Global Regulatory Team (GRT) Product Development Team (PDT), Early Development Team (EDT), and Labeling Working Groups).  

• Participates 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 7 years relevant drug development experience

• M.D. with minimum of 3 years relevant drug development experience or clinical expe