Associate Director/Director, Global Regulatory Affairs
Global and US Regulatory Lead Roles
The AD/Director, Global Regulatory Lead (US Lead) will be responsible for developing the US regulatory strategies for the project or projects in his/her remit. In this capacity, the GRL has US regulatory accountability for the program, working with the Global Regulatory team (regions, Regulatory CMC, Regulatory Operations, labeling) for developing robust regulatory strategies. Specific responsibilities include:
Represents GRA as an Ad hoc member of the cross-functional project team and provides regulatory input for the project(s) globally. In this capacity, the GRL is the point of contact for the business on US regulatory issues for the project. The GRL will work closely with members of the Global Regulatory Team (CMC, operations, regions, labeling), and may ask members of the Global Regulatory Team to participate in cross-function project team meetings on an agenda-driven basis.
The GRL will ensure the development of robust US regulatory strategies for the program and will be accountable for contributing to and maintaining a Global regulatory strategy document. The regulatory strategy document will evolve over the course of a project’s development but should include the overall regulatory strategy and how it will deliver on the TPP, regional specific needs, regulatory environment, regulatory risks and mitigations, global submission strategies, and reimbursement strategies. The GRL will work with the global regulatory team to ensure that relevant input from all GRA functions is vetted and included in the regulatory strategy.
The GRL is accountable for presenting and defending the US strategy at all GRA peer reviews conducted in a timely manner ahead of key governance meetings and major (issue-driven) ad hoc reviews by Sr. Management. The GRL is also accountable for ensuring that GRA Sr. Management is aware of any major issues with the project, including any changes to risks.
The GRL will work with the labeling strategists and regional groups on the CDD and ensure appropriate labeling content based on the clinical program and TPP. The GRL will also work with the labeling strategist and regions to develop region-specific labels.
The GRL will also interact directly with the US HAs as needed for the project.
The GRL will work transversally to ensure a properly functional and informed Global Regulatory Team.
The GRL will ensure communications from HAs are properly communicated to the business and up through GRA Sr. Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
The GRL will line manage, and/or coach mentor, junior staff supporting the program.
The GRL may at times be designated by the Global GRL to act in their place at Global Team and Governance meetings.
Knowledge, Skills and Other Experience
Strategic extensive knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Demonstrate solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical market place and familiarity with medical terminology. Understands 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.
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows the ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.
Build networks to obtain cooperation without relying on authority.
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values.
10 years of industry experience, with at least 10 years working in regulatory affairs (regionally or globally). Experience in other relevant functions will be considered.
Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.), multiple SNDAs or extensive experience with marketed products.
BS in a scientific discipline. An advanced degree preferred.
Internal Number: R2521367
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