Global Regulatory Team Lead

28/06/21

Location

Technologiepark-Zwijnaarde 21, Gent, Belgium

Function type

Manager

Vacancy

About the opportunity

Join Sanofi Genzyme as Global Regulatory Team Lead where you will be part of the Global Regulatory Affairs (GRA) organization within the Rare Disease/Rare Blood Disease Therapeutic Area. You will be responsible for developing long and short-term regulatory strategies for the projects and products under your accountability. It is a key leadership position providing the opportunity to have a substantial positive impact on the development of Sanofi’s Rare Disease and Rare Blood Disease portfolios.

About Sanofi Genzyme

Sanofi Genzyme is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.

Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.

About growing with us

In this role you will…

  • Represent GRA as a core member of the cross functional Rare Disease/Rare Blood Disease project teams and Rare Disease/Rare Blood Disease Global Brand teams and provide overall regulatory input for the project(s) globally. In this capacity, you are the single point of contact for the business on regulatory issues for the project(s).

  • Ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for your assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS).

  • Work transversally to ensure a properly functional regulatory sub-team. You facilitate the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.

  • Be accountable to present the global regulatory strategy/position to senior management / governance committees as needed.

  • Work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP.  You will also work with the labeling strategist and regions to develop region specific labels. 

  • 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 analyze 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, you may also serve as the US Regulatory Lead.

About you

Qualifications/Education & work experience

  • Bachelor's degree and at least 6 years in Regulatory Affairs or relevant industry experience.

  • Master’s, PharmD, PhD degree and at least 4 years in Regulatory Affairs or relevant industry experience.

  • Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.

  • Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA).

  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance.

  • Understanding of the Global (including US, EU in Japan in particular) and U.S. pharmaceutical marketplace and familiarity with medical terminology.

  • Languages: English.

Competencies

  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.

  • Ability to plan, organize, motivate and lead others.

  • Ability to work well within cross-functional teams.

  • Develop collaborative relationships to facilitate the accomplishment of work goals.

  • Solid oral communication and writing skills.

  • Generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.

  • Show ability to use appropriate interpersonal styles and techniques and can modify behaviour to gain acceptance of ideas or plans.

  • Ability to 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.

Inspire your Journey, what Sanofi can offer you:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team.

  • An individual and well-structured introduction and training when you onboard.

  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully.

  • As a globally successful and constantly growing company, Sanofi provides international career paths as well.

This is our Sanofi, Discover yours.

We are proud to have been awarded Global Top Employer 2021.

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