Regional Regulatory Strategist (Senior Manager), Rare Disease at Pfizer

What You Will Achieve

• You will represent Pfizer as an Approval Liaison in the regulatory affairs team. You will play the critical role of providing strategic product direction to teams while interacting with regulatory agencies and negotiating with them to expedite approval of pending registrations. Due to your expertise, you will be the Regulatory Liaison for Emerging Markets on the project team throughout the product lifecycle and a regulatory representative to marketing or research project teams and government regulatory agencies. Your understanding of regulatory procedures will help in development of submission of product registration, progress reports, supplements, amendments, and periodic experience reports.
• As a Senior Manager, your advanced knowledge of the principles and concepts in the discipline and comprehensive knowledge of other disciplines will enable you to lead complex projects across the division. Your ability to develop and manage plans will facilitate in achieving objectives, interpreting internal and external business challenges, and recommending best practices for improvements. While managing complex project environments, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve targets for the division.
• It is your hard work and leadership that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Provide support for Emerging Markets Rare Disease regulatory strategy contribution that aligns with regional and global business needs.
• Lead and manage Rare Disease regulatory strategy aspects of projects/products across the lifecycle, including the preparation and submission of correspondence and applications to regulatory agencies.
• Act as direct liaison with regulatory authorities / Pfizer country offices to facilitate the prompt review and approval of applications.
• Supporting early and late clinical development activities by providing regulatory advice.
• As appropriate develop and implement regulatory strategies to support initial registrations.
• Maintains product licenses across all product platforms.
• Understand regional regulatory environment and communicates priorities to global stakeholders.
• Support delivery of project regional strategy.
• Participate on Regulatory Team and contribute aligned (i.e. with other regional stakeholders) regional strategy for assigned project / products.
• As appropriate accountable for regional regulatory agency interactions.

Qualifications

Must-Have

• B.S. degree in a biological science field with substantial regulatory experience. A higher degree (MSc or PhD) may be an advantage but is not essential.
• Strong organizational/negotiation skills and time management capability to prioritize multiple projects.
• Proven ability to manage complex regulatory issues. Rare Disease drug development experience an advantage.
• Strong verbal and written communication skills.
• Demonstrated experience of effective delivery in a complex matrix environment.

Nice-to-Have

• Basic knowledge in drug development science.
• Understanding of business and financial environment.
• Ability to operate in both strategic and tactical settings.
• Ability to manage multiple projects, create and manage project timelines.