Senior Associate, Global Regulatory Strategy Oncology

Senior Associate, Global Regulatory Strategy for Oncology

• United States - Massachusetts - Cambridge
• United States - Washington – Bothell
• United States - Connecticut - Groton
• United States - New York - New York City

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

At Pfizer, we are committed to bringing medicines to the world faster without compromising on excellence and integrity. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer medicines and vaccines. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your role will be instrumental in ensuring that our life-saving treatments reach those in need, ultimately contributing to the betterment of global health.

ROLE

SUMMARY:

• Accountable for ensuring US/regional contribution to Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects.
• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed expectations, maximizing overall project delivery time and probability of success and facilitating post-filing activities
• Partners with key cross functional stakeholders in the Project Teams to ensure required regulatory contributions (line plans, label, NDA/sNDA, IND/CTA, MAA/IRD, variations, license renewals etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
• Develop and submit product registrations, progress reports, supplements, amendments, and periodic experience reports
• Ensures regulatory plans are monitored, progress/variance communicated to Global Regulatory Lead and Senior Management, and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.
• Work with a certain degree of independence on moderately complex assignments and ensures an aligned regional regulatory position is reached for all key issues for assigned project/s, and that these regulatory positions supporting the regional business are championed and communicated.
• Engages in appropriate activities in order to influence the regional regulatory environment through OGRS-In Country colleagues, Agency contacts, and/or Trade Associations as appropriate.
• Ensures business compliance and implementation of and adherence to Regulatory standards.
• Develops and maintains, directly or indirectly, constructive working relationship with Health Authority contacts in the assigned region.

BASIC QUALIFICATIONS:

• Bachelors degree with at least 2 years of experience
• Effective delivery in a complex matrix environment
• Regulatory experience, including knowledge of New Drug Application (NDA) and Investigational New Drug (IND) submission processes
• Previous experience as a national and/or regional regulatory liaison for at least one product in different therapeutic areas and in different stages of the product life cycle is highly desirable. Equivalent experience, either at a regulatory agency or working on substantive industry
  -government collaborations, can be considered.
• Experience in communicating with FDA as well as participating in/leading such interactions, is preferred
• In-depth understanding of national and regional regulatory legislation and guidelines
• Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs, amendments/supplements, is preferred.
• Communication skills - Ability to…