|Location||Boston, Massachusetts, United States|
Senior Director, Regulatory Affairs
Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.
Working in partnership with the Vice President, Regulatory Affairs:
- Assist in work managing and executing regulatory submissions
- Responsible for NDA & MMA billed submissions
- Ensure regulatory compliance with pre- and post-approval filing and reporting requirements
- Develop response strategies and submissions to regulators
- Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory submission documents
- Develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities
- Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Contribute to the development and implementation of clinical, pre-clinical and CMC, regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
- Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
- Provide regulatory expertise and support nonclinical, CMC and clinical areas for investigational products
- Ensure clinical, nonclinical and CMC programs are designed and implemented to meet regulatory requirements
- Define regulatory expectations for project teams
- Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
- Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
- Perform as the back-up to VP RA at regulatory meetings and liaison with FDA and other regulatory authorities
- Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
- Identify and assess regulatory risks for assigned projects or programs.
- Prepare and deliver effective presentations for external and internal audiences.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Participate and contribute in Health Authority meetings.
- Develop and mentor junior Regulatory staff members.
- Minimum M.S. degree in life/health/technical sciences required
- Minimum 10+ years’ regulatory experience or a PhD/PharmD or equivalent with at least 5 years of experience within the biotech or pharmaceutical industry
- A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications
- Knowledge of global regulatory requirements
- Recent successful NDA experience required, as well as experience within a matrix environment
- Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
- Demonstrate excellent communication skills.
- Ability to represent the department in project teams.
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
- Demonstrated effective cross-cultural awareness and capabilities.
- Experience in interfacing with relevant regulatory authorities.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
- Knowledge and understanding of applicable regulations.
- Experience in interpretation of regulations, guidelines, policy statements, etc.
- Computer literate.
- Sensitivity for a multicultural/multinational environment.