Senior/Director, Global Regulatory Strategist (Secondment - 12 Months)
About The Position
The Senior/Director, Global Regulatory Strategist develops and implements regulatory strategy aligned with business needs for the Internal Medicine portfolio, with a focus on Obesity and Chronic Weight Management assets in assigned regions. The role provides global regulatory expertise as a member of the Global Regulatory Strategic Team (GRST) and other cross-functional forums, and leads strategies for assigned projects and products in line with commercial goals. It is accountable for timely global submissions and approvals with commercially attractive labelling across key markets, and for effective regulatory interactions with Health Authorities worldwide. The strategist develops global regulatory strategies and implementation plans, including core labels and risk registers, integrating input from regional and in-country regulatory colleagues. The role partners with project teams and customer groups, including commercial teams, to deliver regulatory contributions to agreed time and quality standards. It monitors regulatory plans, communicates progress and variances, mitigates risks, and aligns and communicates global regulatory positions on key issues. The position coordinates global submissions and works with partner groups to ensure complete, timely, fit-for-purpose submission packages. It also supports post-filing activities and operational work such as submissions, responses to regulatory queries, and labelling. The role helps influence the global regulatory environment, ensures compliance with regulatory standards, and develops constructive working relationships with Health Authority contacts across key markets. This is a 12-month secondment. The position is considered flexible, with colleagues expected to follow site Log In For Your Day requirements (approximately 2.5 days per week in the office). The employee’s current work location will not change. The secondment must be funded by the secondee’s home market. Candidates must have permanent U.S. work authorization; visa sponsorship is unavailable.
Requirements
- Bachelor’s degree.
- At least 8 years of experience.
- Experience outside regulatory strategy, particularly in medical affairs, is positively weighed.
- Ability to develop and implement global regulatory strategies with stakeholders in alignment with commercial goals.
- Ability to support timely global submissions and approvals with commercially attractive labelling across key markets.
Nice To Haves
- Master’s degree with at least 7 years of experience; or a PhD with at least 5 years of experience; or an MD with at least 4 years of experience.
- Breadth of diverse leadership experience and capabilities, including influencing and collaborating with peers, developing and coaching others, and overseeing and guiding colleagues’ work to achieve meaningful outcomes and business impact.
Responsibilities
- Develop global regulatory strategies and implementation plans, including core labels and risk registers, for assigned projects and products.
- Integrate input from regional and in-country regulatory colleagues into regulatory strategies.
- Ensure regulatory contributions support strategy objectives, agreed standards, project delivery timelines, and probability of success, including post-filing activities.
- Partner with project teams and customer groups, including commercial teams, to provide regulatory contributions that meet business needs and agreed time and quality standards.
- Manage global submissions to ensure complete and timely submission packages across key markets.
- Participate in project teams and coordinate with partner groups to prepare fit-for-purpose submission packages.
- Monitor regulatory plans, communicate progress and variances to the GRL and Senior Management, and mitigate risks.
- Align and communicate global regulatory positions on key issues and champion those positions across regions.
- Influence the global regulatory environment through regional and in-country colleagues, Agency contacts, and Trade Associations as appropriate.
- Ensure business compliance with and adherence to Regulatory standards.
- Develop and maintain constructive working relationships with Health Authority contacts across key global markets.
- Provide assigned operational support, including submission coordination, responses to regulatory queries, labelling activities, and other regulatory tasks.
- Provide global regulatory strategic expertise as a member of the GRST and other cross-functional forums.
- Ensure optimal regulatory interactions with Health Authorities worldwide for the Obesity and Chronic Weight Management portfolio.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
