Senior Director Regulatory Affairs Liaison- General Medicine

Job Description

Our Regulatory Affairs team in General Medicine advances medical innovation to patients by establishing clear, timely, and robust strategies for registration enabled by engagement with global health authorities. We work across functions and geographies to advance development programs and maintain licensure for the General Medicine portfolio worldwide. We seek a leader with a growth mindset, demonstrated by intellectual curiosity and the ability to navigate complex regulatory challenges with rigor and professionalism.

The Senior Principal Scientist, Regulatory Affairs Liaison is responsible for the development and implementation of worldwide regulatory strategy for programs in the General Medicine therapeutic area with specific focus on development programs in cardiovascular/renal/respiratory. The individual functions with a high degree of independence and provides strategic regulatory oversight for assigned programs to optimize labeling and obtain shortest time to approval by regulatory agencies. The individual should be adaptive to change and embrace entrepreneurship.

The Senior Principal Scientist will independently manage assigned programs.  As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development. Programs may be complex with more than one indication, formulation or have an external business partner. In addition, the role may require periodic non-program assignments in General Medicine.

Primary activities include, but are not limited to:

• Report to Executive Director or Associate Vice President, General Medicine

• Oversee the global regulatory strategy development and execution for their assigned programs in the cardiovascular/renal/respiratory therapeutic area to optimize labeling and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously

• Provide expert advice as the GRL to Early Development Teams (EDT)/Product Development Teams (PDT)and regulatory single point-of-contact for products within and external to Global Regulatory Affairs and Clinical Safety (GRACS) on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug

• Provide leadership by leading the Global Regulatory Team (GRT) for assigned cardiovascular/renal/respiratory programs which coordinates global, 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 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 teams for meetings with FDA at any phase of drug development

• Coordinate interactions with global regulatory agencies through Regulatory Affairs Europe, Regulatory Affairs International, 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 Global Regulatory Affairs within internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, PDT, EDT, and label development team)

• 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

Minimum Education & Experience Requirements:

Degree in biological science or related discipline

• B.S., with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs

• M.S. with minimum of 10 years relevant drug development experience, with a majority in regulatory affairs

• M.D. with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs

• PhD/PharmD with minimum of 7 years relevant drug development experience, with 5 years in regulatory affairs