The Director of Global Regulatory Affairs will represent regulatory in the development team(s); working with other regulatory team members (e.g., CMC and Operations), leveraging regulatory consultants as needed, and collaborating with colleagues within Global Quality, Regulatory and Safety (GQRS) and the Research & Develop organization. The Director will report to the Head of GQRS.
This position is accountable for developing and executing innovative global regulatory strategies for development compounds in the areas of rare disease, specifically to:
1. Devise and implement global regulatory strategies for our client and its programs
o Create global regulatory plans for products in scope, based upon relevant guidance documents and precedents, innovative and logical regulatory thinking, and company performance objectives
o Guide teams in developing strategic direction for assets/indications and provide leadership for regulatory interactions and other external interactions. Anticipate and interpret key trends and changes in the global and US regulatory environment and provide strategic guidance regarding development plan(s)
o Provide leadership in researching, recommending and implementing new processes in the department; working with project teams to determine the content of INDs, NDAs, and global CTAs and MAAs where needed.
o Define regulatory strategies and provide intelligence for assigned programs in rare and orphan diseases. Lead and participate in department initiatives, task forces and training. Provide regulatory due diligence assessments for business development
2. Effectively manages internal and external relationships to drive performance
o Build and maintain strong working relationships with functions key to the success of product development, including Regulatory, Quality and Safety, Research and Development. Routinely interact and enhance collaborative relationships with colleagues through Global Regulatory Affairs, including other strategists, CMC and Operations
o Build and foster trust-based relationships with global Health Authority leaders. Keep abreast of changes in the global regulatory environment and adapt strategies appropriately
o Ensure a strong working relationship with external partners including alliance partners, regulatory agencies, advocacy organizations and consultants. Provide leadership and strategic direction with regulatory colleagues in development of partnership agreements
Skills and Behavioral expectations
* High-performance orientation, individually and as a team member
* Effectiveness at collaboration and relationship building in the functional/program team matrix, as well as external
* Facilitates exceptional decision-making, thoughtful tradeoffs, and conflict resolution
* Demonstrates an innovative yet logical approach to regulatory thinking
* PhD, MD, PharmD or MS with commensurate experience
* 7+ years of global regulatory experience in a strategy function, from early to full development
* Understanding of global and US policy, laws, regulatory and guidance/guidelines
* Demonstrated high-level competency in drug development processes and understanding of scientific content and complexities; especially in rare and orphan disease development
* Direct experience in leading the development of global and US regulatory strategies and leading teams through HA interactions and to drug/biologics approvals
* Ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals
* Global regulatory experience - familiarity with regulations in countries beyond the US (e.g., EU
* Understanding of the global characteristics of clinical trials and supply base
* Orphan and rare disease experience
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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