Sanofi Group Senior Manager Regulatory Affairs in Bridgewater, New Jersey
The Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Sanofi Genzyme Global Business Unit (GBU), supporting the immunology and inflammation therapeutic area, more specifically responsible for the product dupilumab. He/she is responsible for developing long and short-term regulatory strategies for respiratory indication under development for dupilumab. 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 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.
Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
Depending on the program assignment, the GRTL may also serve as the US Regulatory Lead.
Impact on the organization
- A robust regulatory strategy, whether for projects on the market (Commercial) or these in development, is critical for the success of the business and for the company to meet its goals.
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 in Japan in particular) and U.S. 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 5 years in Regulatory Affairs or relevant industry experience.
Master’s, PharmD, PhD degree and at least 3 years in Regulatory Affairs or relevant industry experience.
Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.