Eagle is currently seeking a motivated Director/Senior Director, Regulatory Affairs reporting to the Senior Vice President, Regulatory Affairs. The Director/Senior Director, Regulatory Affairs primary responsibilities include supporting the development of strategic planning for the Regulatory Affairs department to insure alignment with Corporate objectives.
-Insure the department organizational structure, systems and competencies are developed and maintained to meet departmental requirements and corporate objectives.
-Identify requirements and direct the implementation of new regulatory policies and procedures and processes, as needed.
-Direct and coordinate the composition of regulatory submissions including INDs, NDAs, ANDAs and FDA meeting requests and briefing documents to insure all submissions meet FDA expectations as described in current guidance and comply with applicable regulations.
-Provide effective management and oversight of the commercial product portfolio by ensuring compliance with post-approval regulatory filing requirements for NDAs, INDs, ANDAs including review and approval of post-approval changes.
-Develop and implement regulatory project time lines for pre- and post-approval submissions that align with corporate goals and insure adherence to pre-established project time lines by effectively managing departmental and external resources.
-Serve as the Regulatory Affairs Representative on project teams.
-Provide strategic regulatory guidance to internal and external stakeholders for the R&D and commercial product portfolios and insure cross-functional strategies are in alignment.
-Maintain awareness and communicate with key stakeholders regarding evolving regulatory requirements.
-Bachelor’s Degree in Life Sciences preferred.
-10+ years regulatory experience with 3-4 years leadership experience at a Director level or equivalent.
-Domestic and international travel as required.
Eagle Pharmaceuticals offers competitive pay, benefits and a flexible work environment. If interested, please apply on our website.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.