Major duties

Description

Project/Product regulatory support

· 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.

· Act as Global Regulatory Lead (GRL) on at least one project team, working with global regulatory affairs team to provide global strategy for new indications for key portfolio product(s)

Regulatory Submissions

· 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.

Sustaining Regulatory Support

· 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, including acting as primary regulatory reviewer on Promotional Review Committee.

Labeling

· Work with Commercial and R&D colleagues to develop ‘best in class’ labeling.

· Review product labeling for regulatory compliance

Liaise with regulatory agencies

· Primary point of contact for Global Health Authorities. Communicate regulatory requirements and risks to internal stakeholders.

· Interact with contract manufacturers, affiliates and distributors.

Regulatory Intelligence

· Conduct and analyze regulatory research providing guidance to the business and project teams on past precedence, competitive landscape and regulatory intelligence.

Management

· Mentor and provide guidance to staff. 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.

Education

-Bachelor’s Degree in scientific or health discipline

Required

-Master’s degree in scientific or health discipline

Preferred

Professional experience

-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

Preferred

-Experience with EU/International Regulatory

Preferred

-Experience with Combination Products, particularly drug/device

Preferred