Senior Director Regulatory Affairs Liaison- General Medicine

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.

Position Description:

The Senior Director, Global Regulatory Lead, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the General Medicine therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects, functioning as the single, accountable, global point of contact on those projects. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/Biologics. 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 for all submissions and associated documentation. Provides expertise as 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, General Medicine

• Develops worldwide product regulatory strategy to optimize label 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 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 internal company committees to provide regulatory advice and approval according to the committee charters (including therapeutic area Document Review Committees, Product Development Team, Early Development Team, and label 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

Position Qualifications:

Education Minimum Requirement:

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

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

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

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

Required Experience and Skills:

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

Preferred Experience and Skills: