Reports to: Sr. Director, Regulatory Affairs
Location: Greater Boston Area
Email: resume@bpsearches.com
Position Summary
Reporting to the Senior Director of RA, the Director of RA will work with a cross-functional team to implement regulatory strategy, data and submission packages to US and international agencies.
Summary of Key Responsibilities:
Responsibilities include actively contributing to the development and implementation of regulatory strategy for specific projects including identifying and assessing regulatory risks, serving as the RA representative on project teams, active involvement in the writing and review of regulatory submissions, interfacing with authorities, coordinating all aspects of regulatory submissions and proactively keeping updated on regulatory requirements worldwide.
Qualifications:
- BS in Life/Health Sciences required, MS/PhD preferred, with a minimum 8 years’ pharmaceutical/biotechnology industry experience including 5+ years regulatory experience working on biopharma programs
- Excellent written and communication skills
- Attention to detail
- Ability to work independently and within project teams, committees, etc. to attain group goals
- Ability to represent the department on project teams
- Ability to maintain files and documentation, updated and inspection-ready
- Demonstrate strong organizational skills, including the ability to prioritize personal and direct report’s workload
- Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Previous managerial experience preferred
- Experience in interfacing with regulatory authorities
- Experience in leading regulatory submissions including IND, NDA/sNDA submissions, briefing documents, etc.
- Experience and knowledge in the preparation of electronic submissions
- CMC experience is a plus
- Knowledge and understanding of US and ex-US regulatory regulations
- Highly computer literate (Word, Excel PowerPoint), including formatting and getting document submission-ready.