Job Number: 8823
The Director of Regulatory Affairs is responsible for providing regulatory direction and management for specialty US marketed products supporting multiple therapeutic areas. This includes developing, coordinating and executing regulatory strategies and guiding staff at all levels on appropriate regulatory strategies. The Director will create strong and effective relationships with other regional and functional regulatory peers and staff on the development of ex-US submission strategies and provide support as needed. This role would represent Regulatory Affairs on cross-functional teams, interact with FDA and ex-US health authorities as needed, and oversee maintenance activities for regulatory filings to ensure timely and high quality submissions. The Director will act as a liaison between Regulatory Affairs and Brand teams and should have strategic knowledge related to 505(b)(2) submissions, INDs and NDAs, as well as promotional material review.
Defines and implements U.S. Specialty regulatory strategies; ensuring that all regulatory requirements/commitments are met with respect to regulatory submissions for NDAs in US
Formulate and implement Regulatory strategies and plans to achieve efficient and competitive product development and marketing.
Provide Regulatory direction for the coordination and preparation of Regulatory submissions consistent with Regulatory requirements to meet corporate strategy and timelines.
Act as Regulatory Lead for the review of documentation prepared by Brand and Marketing teams
Provide Regulatory review and approve of internal documentation supporting product development activities (e.G. Clinical protocols, clinical study reports, statistical analysis plans, etc.)
Assist and at times be the lead in communications and negotiations with Regulatory Agencies
Responsible for the preparation/coordination/submission and providing Regulatory strategy for responses to deficiency letters/queries from FDA on pending and approved applications
Responsible for preparation of information and related activities for meetings with drug regulatory agencies as well conduct of meeting and preparation of accurate meeting minutes
Provides support for due diligence activities associated with business development as required
Responsible for the review of Regulatory filings such as drug applications and application correspondence to provide regulatory background to all departments in response to specific departmental requests.
Maintains a detailed knowledge of FDA regulations, guidelines and standard procedures
Manages all promotional material review based on FDA regulations.
Other duties as assigned
MS or PhD (scientific and clinical pharmaceutical) required.
8+ years of experience with a successful record of submissions and approvals of NDA and ANDA applications to the FDA
5+ years in a management role
Experience interfacing with the New Drug Divisions of the FDA and other US Regulatory Agencies
Background in developing clinical trial designs necessary for NDA products requiring clinical studies. Further, experience with 505b2 pathways for US.
Experience with international product regulations in order to support the International group in preparing regulatory strategy and submissions for registering products in ROW is also desirable.
Excellent written and verbal communication skills are required, as well as experience working as part of cross-functional, multinational teams