Associate Director Global Regulatory Sciences - Oncology

Position Responsibilities

• Develop global regulatory strategy in development and through life cycle management taking into account all relevant guidance, commercial needs, and company objectives.
• Lead regulatory dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions.
• Work with cross-functional groups to define and manage contributions to submissions.
• Write regulatory documents (e.g., new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); review core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
• Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol amendments in compliance with HA deadlines.
• Participate in and/or lead regulatory interactions with FDA, as assigned.
• In collaboration with the global regulatory team (GRT), develop global submission plans and Health Authority interaction plans.

Skills/Requirements

• Solid scientific background (PhD, MD, Pharm.D., BS or MS in regulatory science).
• 4-8 years pharmaceutical industry experience; significant experience in regulatory affairs (e.g., 3-5 years).
• Thorough knowledge of the drug development process, IND and NDA process.
• Demonstrated experience in preparing FDA submissions.
• Strong experience with US Regulatory submissions and dossiers (e.g., INDs; NDAs).
• Inter-dependent partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment.
• Experience in successfully leading teams; ability to broadly represent the regulatory functions on project teams within BMS and across alliance.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to details.
• Demonstrates ownership of results within (and beyond) area of responsibility.
• Looks for opportunities for continuous improvement.
• Strong team player, using both internal and external resources to execute regulatory activities and working across organizational, functional, and geographic boundaries to achieve company goals.
• Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
• Experience applying project management techniques within teams.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives.
• Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others; ability to drive quality decision making, to organize and prioritize tasks and negotiate.
• Some travel may be required.