Senior/Director, Global Regulatory Strategist (Secondment - 12 Months)

WHY PATIENTS NEED YOU

Global Regulatory Sciences (GRS) serves as strategic leader and catalyst enabling high quality, efficient, innovative, label-focused global development that changes patient lives throughout the product life cycle.

WHAT YOU WILL ACHIEVE

The Senior/Director, Global Regulatory Strategist, will be responsible for developing and implementing regulatory strategy that aligns with business needs for the Internal Medicine portfolio, focused on Obesity and Chronic Weight Management assets in their designated regions. The purpose of this role is to:

• Act as a global regulatory strategist for the Obesity and Chronic Weight Management portfolio.

• Provide global regulatory strategic expertise as a member of the Global Regulatory Strategic Team (GRST) and other cross-functional forums.
• Lead the development and implementation of global regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
• Be accountable for timely global submissions and approvals with commercially attractive labelling across key markets.

• Provide operational support of activities as assigned.

• Be accountable for ensuring optimal regulatory interactions with Health Authorities worldwide in relation to the Obesity and Chronic Weight Management portfolio

HOW YOU WILL ACHIEVE IT

• Accountable for developing Global Regulatory Strategies and implementation plans (including core labels, risk registers) for assigned projects, integrating input from regional and in-country regulatory colleagues.

• Ensures regulatory contributions achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.
• Partners with project teams and other customer groups (e.g. commercial teams) to ensure required regulatory contributions meet business needs and are provided to the project teams, to agreed time and quality standards.

• Accountable for managing global submissions to ensure completeness and timeliness of submission packages across key markets. Participate in project teams for assigned projects/products and actively coordinate and follow up with partner lines to ensure fit-for-purpose submission packages.

• Ensures regulatory plans are monitored, progress/variance communicated to GRL and Senior Management and any risks (from emerging technical data, changing internal objectives or external threats) mitigated.

• Ensures an aligned global regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the global business are championed and communicated across regions.
• Engages in appropriate activities to influence the global regulatory environment through regional and 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 relationships with Health Authority contacts across key global markets.

• Support of operational activities as assigned including coordination of submissions, responses to regulatory queries, labelling activities and other regulatory tasks.

QUALIFICATIONS

Must-Have

• Applicant must have a bachelor's degree with at least 8+ years of experience.
• Experience outside regulatory strategy, in particular medical affairs, will be positively weighed to bring broader perspectives.
• Provide global regulatory strategic expertise as a member of the Global Regulatory Strategic Team (GRST) and other cross-functional forums
• Lead the development and implementation of global regulatory strategies in agreement with key stakeholders for assigned projects/products and in line with the commercial goals.
• Be accountable for timely global submissions and approvals with commercially attractive labelling across key markets

• Provide operational support of activities as assigned.

• Be accountable for ensuring optimal regulatory interactions with Health Authorities worldwide in relation to the Obesity and Chronic Weight Management portfolio

Nice-to-Have

• Master's degree with at least 7+ years of experience; OR a PhD with 5+ years of experience, OR a MD with 4+ years of experience.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact

ORGANIZATIONAL RELATIONSHIPS

Reports to The Obesity Global Regulatory Portfolio Lead (GRPL)

Works with GRS colleagues and relevant project team(s) members (i.e. Clinical and Project Management, Development Operations, Global Regulatory Sciences, Worldwide Risk Management, Worldwide Safety Sciences, Pharmaceutical Sciences, Global Manufacturing Compliance and Legal).

Partners with regional colleagues, including GRS-in Country colleagues, Medical and Commercial colleagues, to provide a regional position.
Works directly or indirectly with external contacts in Regulatory Agencies within assigned region, as well as relevant experts and key opinion leaders.
Ensures alignment with GRPL and GRL.

OTHER JOB DETAILS

• Last Date to Apply for Job: October 28, 2026
• Additional Location Information: NY - New York City
• Eligible for Relocation Package – NO
• Secondment 12 months
• If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment.  Please refer to the Fleet Policy and Procedures document for more information.
• There will be no change to your current work location.
• Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
• Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.