Responsible to proactively develop innovative, robust US regulatory strategies and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development for rare disease indications which adhere to US regulatory and company guidelines.
Represent the NA GRA perspective as a member of project specific cross functional global regulatory team (GRT) and be accountable to develop and maintain US aspects of regulatory strategy documents.
Lead the strategic development of briefing materials and prepare teams for US FDA meetings.
Participate in the development of and assess the appropriateness of submission documentation to support successful INDs/NDAs/BLAs.
Represent the company at US FDA for assigned projects.
Work with the NA labeling strategist and the Global Regulatory Team to develop US prescribing information.
Work with and participate on multi-disciplinary matrixed project teams to successfully meet project deliverables while adhering to regulatory requirements for programs and products.
Consult with senior management to develop and communicate regulatory strategies and advice for products and programs.
Participate in the development and monitoring of the US regulatory environment and updating of standards and processes related to drug and biologics US regulations.
Supervise, and/or coach mentor, junior staff supporting regulatory team.
Ensure compliance with all regulatory and internal company policies
At least 10 years’ regulatory experience in pharmaceutical drug development.
Solid working knowledge of drug development process and US regulatory requirements.
Demonstrated experience developing and implementing regulatory strategies for US INDs, BLA, and/or NDAs
Experience with rare disease drug development.
Demonstrated experience successfully operating in a global environment.
Advanced scientific degree preferred. B.A./B.S. or higher degree (s) in the sciences, or health related field minimum, with 8 years regulatory experience.
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving US regulatory policy and guidance
Direct interaction/negotiation experience with US FDA.
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.
Ability to work well within cross-functional globally oriented teams
Demonstrates excellent oral communication and writing skills
Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology. Ability to understand issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Ability build networks to obtain cooperation without relying on authority
Unquestionable ethics, professional integrity, and personal values consistent with the company values