Associate Director Regulatory Affairs
Metro West Area, MA
Currently seeking a Regulatory Affairs Associate Director to fill a position in the Metro West, MA Area. Preferred candidates will possess a Master’s Degree in a scientific field with at least six years of biopharmaceutical industry experience and five years emphasis in regulatory affairs.
Responsibilities of the Associate Director Regulatory Affairs
- Lead the regulatory review of promotional materials for three recently approved drugs and support regulatory for programs in development
- Be the primary regulatory representative on the Promotional Material Review Committee.
- Contribute to IND and NDA strategy
- Lead the planning, coordinating, authoring, and preparing regulatory submissions including both pre-approval and post-marketing submissions
- Ensure the execution of regional regulatory plans in line with the product’s global registration strategy in collaboration with the global regulatory leader
- Manage and communicate timeline changes related to health authority submissions
- Review of nonclinical, clinical and CMC documentation (e.g. nonclinical study reports, clinical protocols/study reports, investigator’s brochures, CMC information/data) and contribute to content as needed
- Lead and coordinate local project team members in developing strategy for applicable documents/activities
- Lead regional health authority meeting and interface directly with the local health authority
- Accountable in conjunction with the GRL for maintaining the company core data sheet along with the regional product information documents through the product life cycle.
- Provide updates at the Global Regulatory Team (GRT) meetings and project teams as needed.
Requirements of the Associate Director Regulatory Affairs
- BS in a scientific field, Master’s degree or PhD is preferred
- Minimum 6-10 years of biopharmaceutical industry experience with 5 years emphasis in regulatory affairs ideally spanning Phases I-IV
- Prior history with post-marketing/brand optimization strategies, promotional review, commercial regulatory affairs
- Solid understanding of FDA and ICH regulations/guidance pertaining to pharmaceutical/biologics development
- Leadership role in health authority negotiations and experience interacting with the FDA
- Experience developing regional and global regulatory strategies in coordination with clinical plans and marketing objectives
- Proven ability to analyze and interpret efficacy and safety data
- Major involvement in NDA/MAA/CTD submissions and approval
- Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions
- Excellent operational skills including planning, organizing and ability to motivate and lead others
- Excellent verbal and written communication skills and comfortable presenting to all levels of an organization including its Senior Management