Global Regulatory Affairs Policy & Intelligence Lead

CDI
Neuilly-sur-Seine
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Sanofi
Sanofi

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Descriptif du poste

SANOFI CHC PURPOSE AND ASPIRATION

At Sanofi Consumer Healthcare, we have one shared mission – we work passionately, every day, to ‘serve healthier, fuller lives’ now and for the generations to come.

In order to do so, we strive to act as a force for good by integrating sustainability along our business and employees’ mission and operate responsibly from both a social and environmental point of view.

Everything we do is centered around people’s interests – our consumers, our customers, healthcare professionals, and our employees – across the world.

We are building loved brands that serve 1bn consumers worldwide, through our key platforms: Allergy, Physical & Mental Wellness, Pain, Digestive Wellness and Cough, Cold & Flu.

We aspire to become the best Fast Moving Consumer Health (FMCH) company In & For the world and we aim to build a work environment where people can thrive, grow, enjoy and be at their best.

JOB PURPOSE

The Regulatory Science, Policy and Intelligence Lead directly lead and manage the CHC Global Regulatory Affairs, Policy, and Intelligence related activities.

The head will provide  thought leadership to bring Scientific Affairs to the forefront of building global and strategic positioning, to advance Regulatory Science , for a fit for purpose & efficient regulatory strategy that support  value creation, to shape  the regulatory policy & environment and guide the development of policy positions for external influence and for guiding internally an innovative product development. .

The head  will be strong advocate of “Self-care” by increasing external awareness about existing gaps in healthcare regulations, by pushing for establishing a self-care tailored regulatory framework empowering consumers &  addressing their unmet needs 

The Head of Scientific Affairs Policy and Intelligence is responsible for overseeing all aspects related to 3 Pillars:

  • Regulatory Science & Policy: Providing Leadership and strategic direction to influence CHC regulatory policy globally across geographies.
  • Regulatory Intelligence : Anticipating & Interpreting the key trends of  CHC regulatory environment to predict threats &  business impact, and allow proactive mitigation strategies
  • Regulatory Advocacy roadmap execution: Developing and following global execution  of advocacy strategies supportive of Sanofi’s CHC business with Regions.

KEY RESULTS/ACCOUNTABILITIES  

- Shape the Regualtory environnement in line with business impertatives & Commercial opportunities.

- Liaise directly with Publica Affairs Leads to secure our future business growth

- Lead the monitoring of regulatory environment by providing targeted newsletters with digested content of  key changes related to Quality, Safety & efficacy guidelines, sustainability Trends, ingredients emerging risks, RWE, Rx-to-OTC Switches, e-commerce etc., anticipating regulatory trends and providing actionable insights with impact assessments of the evolving regulations, highlighting  threats but also emerging opportunities in various markets and regions.

- Lead Harmonisation of Key Regulatory topics (ICH, WHO guidelines) of relevance to self-care portfolio Secure the Unique strategic CHC scientific intelligence platform to sharpen our competitive edge & capabilities & for driving local agendas with health authorities.

- Identify of priority regulatory policy areas for Sanofi CHC in collaboration with subject matter experts.

- Align external regulatory intelligence and engagement initiatives across categories and regions to enable a positive self-care environment and minimize the regulatory burden, aligned to Sanofi CHC strategy & pipeline.

- Support a global cohesive and consistent communication of Sanofi CHC’s external regulatory advocacy/policy positions.

- Support activities with Global Health Authority for regulatory reform, harmonization  and reliance. Sanofi Consumer Healthcare partnering with Trade associations through active participation in regulatory committees and working groups while ensuring a consistent approach with Sanofi key CHC priorities.

- Ensure countries Influence Plan are aligned with global and regional strategic focus.

- Increase CHC external focus by selecting proper topics to be presented in external conferences or to be published in regulatory or clinical/ medical journal (example, RWE use in CHC, e-PIL, How to drive sustainability when facing a diversified portfolio)

KEY WORKING RELATIONSHIPS 

CHC Global Regulatory Affairs, CHC Science Hub Regions/countries, CHC Global Public Affairs; GRA Science & Policy; CHC Science Hub (Medical, Pharmacovigilance, R&D ); CHC GROWTH Hub; CHC Global Digital Business Transformation…

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Education

Degree in Science or Higher degree Ph.D, Pharm.D, or MD

Required knowledge and/or experience

  • 5-10 years’ regulatory experience desirable
  • In depth understanding of the prescription and non-prescription drugs, herbal medicines, vitamins and mineral supplements, food supplements/nutraceuticals, medical devices, digital technologies, cosmetics development, and commercialization process.
  • Previous experience working in regulatory policy and intelligence desirable
  • Ability to work in a complex multi-cultural environment
  • Demonstrated influencing and negotiation skills
  • Excellent communication (written/verbal) and presentation skills
  • Existing relationship with local/regional government legislators, trade associations, committees, administrative staff or other key parties or influencers in the CHC field with emphasis on key CHC markets desirable

Language skills

  • Fluent spoken and written English
  • An Additional language is desirable

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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