Director, Rare Disease/Rare Blood Disorders, Global Regulatory Team Lead, Global Regulatory Affairs
Job Purpose/Job Description:
The Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Specialty Care Global Business Unit (GBU). He/she is responsible for developing long and short-term regulatory strategies for the rare disease and/or rare blood disorders projects and products under his/her accountability. The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products.
Major Activities/Key Responsibilities
Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s).
The GRTL will ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS)
The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed.
The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and Target Product Profile (TPP). The GRTL will also work with the labeling strategist and regions to develop region specific labels.
The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
The GRTL will research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
The GRTL will insure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
The GRTL may line manage, and/or coach mentor, junior staff supporting the program
Depending on the program assignment, the GRTL may also serve as the US/EU Regulatory Lead.
Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
Excellent operational skills including planning, organizing and ability to motivate and lead others.
Ability to work well within cross-functional teams
Can demonstrate solid oral communication and writing skills
Understanding of the Global (including US, EU and Japan in particular) pharmaceutical marketplace and familiarity with medical terminology.
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 ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Strong sensitivity for a multicultural/multinational environment
Unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values
Bachelor's degree and at least 8 years in Regulatory Affairs or relevant industry experience
Master’s, PharmD, PhD degree and at least 6 years in Regulatory Affairs or relevant industry experience
Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.
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