Director Regulatory Affairs Liaison- General Medicine (Hybrid)

Job Description

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:

• Developing regulatory strategy for their assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies.

• Independently manages projects within the General Medicine Therapeutic Area, functioning as the single, accountable, global point of contact on those projects.

• Functions as first liaison 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 extremely accelerated; is an Alliance program; there are multiple indications, the filing is global and/or it is a new disease target with no official regulatory guidance.

• 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.

• Programs may be complex with more than one indication, formulation or have an external business partner.

• 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.

Primary activities include, but are not limited to:

• Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.

• Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.

• 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 (RAE), Regulatory Affairs International (RAI), 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, Confidential Investigator Brochures before release from our company to external agencies and investigators.

• Provide 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.

• Represent 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).  

• 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 7 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:

• Abili