Director, Regulatory Affairs

Merz Group•Raleigh, NC

About The Position

The Director, Regulatory Affairs leads a team of regulatory professionals and is accountable for the regulatory affairs deliverables under their supervision. This position provides guidance on the development and execution of regulatory strategies for new products and oversight of lifecycle management of existing products. The position supports Marketing and Legal teams on regulatory issues with potential business impact, including participating in the Promotional Review Committee.

Requirements

Bachelor’s Degree in scientific or health discipline required.
Minimum 10 years relevant regulatory experience required.
Direct experience with development, preparation and submission of INDs, BLAs, and NDAs required.
Strong knowledge of US drug and biologic regulatory environment and FDA regulations and guidance required.
Previous experience managing people required.

Nice To Haves

Master’s degree in scientific or health discipline preferred.
Experience with EU/International Regulatory preferred.

Responsibilities

Act as both an individual contributor when needed and a coach for other team members on new product development activities.
Actively contribute to the development and execution of global regulatory strategies for development and life-cycle projects.
Work with direct reports to identify, assess and communicate regulatory risks and project issues as well as recommend solutions to R&D senior management.
Interact with direct reports and project team members to ensure high quality and timely regulatory submissions, which may include submission planning and preparation.
Ensure documents are in compliance with current regulations and guidance and provide strategic oversight.
Ensure all national registrations, licenses, listings and other certifications are maintained as required for regulatory compliance.
Support commercialization and maintenance activities of products as needed.
Work with Commercial and R&D colleagues to develop ‘best in class’ labeling.
Review product labeling for regulatory compliance.
Primary point of contact for Global Health Authorities. Communicate regulatory requirements and risks to internal stakeholders.
Interact with contract manufacturers, affiliates and distributors.
Conduct and analyze regulatory research providing guidance to the business and project teams on past precedence, competitive landscape and regulatory intelligence.
Work with direct reports to ensure accurate processing and timely reporting of safety information related to drug products from all sources, in compliance with SOPs and US regulations.
Participation in and coordination of any FDA audits of safety information.
Mentor and provide guidance to staff. May manage and supervise direct reports including work assignments and performance feedback, appraisals and reviews.
Manage regulatory resources (budget and FTE) as needed.
Communicate regulatory requirements and risks to business leadership.
Other duties as assigned.