MAIN PURPOSE OF ROLE :
- Leads/supervises a team of more than 2 professionals within the Regulatory Affairs Sub-Function.
- First level manager of a work team that may comprise professionals, technical and/or administrative staff.
- Typically without budget or hire/fire authority.
- Focuses on mentoring, coaching, and coordination.
MAIN RESPONSIBILITIES :
- As the Team Leader (Professionals) of the Regulatory Affairs Sub-Function, supervises professionals in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- Interacts with regulatory agency to expedite approval of pending registration. Serves as regulatory liaison throughout product lifecycle.
- Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
- Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
- Serves as regulatory representative to marketing, research teams and regulatory agencies.
- Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
QUALIFICATIONS :
Education
- Associates Degree ( 13 years)
Experience/Background
Role: Head - Regulatory Affairs
Industry Type: Medical Devices & Equipment
Department: Legal & Regulatory
Employment Type: Full Time, Permanent
Role Category: Corporate Affairs
Education
UG: Any Graduate
PG: Any Postgraduate
