Director, Head of Global Nemluvio Regulatory Strategy
Galderma•Boston, MA
•Onsite
About The Position
This role leads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage indications. The objective is to ensure regulatory activities are executed in accordance with global regulatory requirements, corporate objectives, and agreed timelines. The position is accountable for the Global Regulatory Affairs team supporting nemolizumab and for driving successful regulatory outcomes across the product lifecycle.
Requirements
- Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU)
- 10 years of experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
- Experience interfacing with regulatory agencies and skill at implementing successful global regulatory strategies
- Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives
- Excellent team interaction skills along with demonstrated ability to work on a cross-functional team
- Experience with international project management
- Focused on effective delivery of objectives, even when working with tight deadlines
- Ability to identify opportunities/major issues and to communicate impact
- Demonstrated ability to deal with rapid change
Responsibilities
- Accountable for global regulatory strategies and global submission plans for Atopic Dermatitis (AD), Prurigo Nodularis (PN) and any newly identified indications
- Leads Nemluvio Global Regulatory Team, establishing team goals, norms, responsibilities, and communication plans
- Accountable for US regulatory strategies for all indications in coordination with US Regulatory Affairs Team
- Primary contact for FDA
- Identify and assess risks associated with product development and recommend strategies to mitigate these risks
- Core member of Nemluvio Global Project Team, provide regular updates to leadership, Nemolizumab product strategy team, and commercial teams
- Ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed
Benefits
- medical, dental, and vision coverage
- a 401(k) plan with employer match
- paid time off
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
