Global Regulatory Affairs Policy & Intelligence Lead > Sanofi > Joboolo BE :
Société : Sanofi Lieu : Machelen Flanders Site source : Talent BE
.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 AffairsPolicy and Intelligence is responsible for overseeing all aspects related to 3 Pillars:
Regulatory Science & Policy:
Providing Leadership and strategic direction to influence CHC regulatorypolicyglobally across geographies.RegulatoryIntelligence :
Anticipating & Interpreting the key trends of CHC regulatory environment to predict threats & business impact, and allow proactive mitigation strategiesRegulatory 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 AffairsLeads 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 regulatorypolicy areas for Sanofi CHC in collaboration with subject matter experts. - Align external regulatoryintelligence 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 GlobalRegulatoryAffairs, 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 REQUIREMENTSEducationDegree in Science or Higher degree Ph.D, Pharm.D, or MDRequired knowledge and/or experience5-10 years’ regulatory experience desirableIn 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 regulatorypolicy and intelligence desirableAbility to work in a complex multi-cultural environmentDemonstrated influencing and negotiation skillsExcellent communication (written/verbal) and presentation skillsExisting 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 desirableLanguage skillsFluent spoken and written EnglishAn Additional language is desirablePursue progress, discover extraordinaryBetter is out there.
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!Pursue , discover Better is out there.
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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Watch our and check out our Diversity Equity and Inclusion actions at ! Sanofi MachelenFlanders