Opella, the Consumer Healthcare business unit of Sanofi, is the purest and third-largest player globally in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market.  

We have an unshakable belief in the power of self-care and the role it can play in creating a healthier society and a healthier planet.

That’s why we want to make self-care as simple as it should be by being consumer-led always, with science at our core. 

Through our unique and balanced portfolio of more than 100 loved brands, including 15 global and local high-growth challengers such as Allegra, Dulcolax and Buscopan, we deliver our mission: helping more than half a billion consumers worldwide take their health in their hands.  

This mission is brought to life by an 11,000-strong team, 13 best-in-class manufacturing sites, and 4 specialized science and innovation development centers. 

We are also proud to be the first major fast-moving consumer healthcare company to achieve B Corp certification. 

Join us on our mission. Health. In your hands.

Job Title: Regulatory Lead Greece/Cyprus

Mission & tasks: Will lead the local CHC regulatory strategy and guidance to the local team ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorisations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment. Be a partner for local business to support the delivery of business objectives within the regulatory framework.

Key contributions & activities: Ensure high quality submissions within timelines agreed with GRA, business and/or health authorities. Maintain optimal resource capacity for performing required regulatory activities. Manage the local RA budget.

Management Responsibilities:

Regulatory Compliance

Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.Ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirementsEnsure local implementation of mandatory SOPs and trainingEnsure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national regulations. Ensure maintenance of regulatory databases.

Health Authority Interactions

Build credible relationships with health authorities, making Sanofi CHC a recognized partner with the agencies and providing regulatory thought leadershipAct as interface between the company and local regulatory authorities, where reasonable.

Portfolio Management

Review and approve promotional and non-promotional materials ensuring their competitive position and compliance with local regulations, code of conduct and internal guidelines.Lead the management of the local maintenance activities and ensure compliance of the marketed product portfolioLead development of the Local Regulatory strategies for geographical extensionsManage with other functions the preparation of local dossiers for the products under development and territory extensionsLead development of local strategies and preparation of OTC switchesEnsure that best efforts are provided to get timely approvals of dossiersLead the regulatory due diligence for local BD opportunities, collaborating with other relevant functions and providing strategic recommendations to enable appropriate portfolio decision makingProvide RA insight and actively identify product portfolio optimization and product pruning opportunities at affiliate level, partnering with IA, Commercial and GRA functions to deliver on product portfolio optimization strategies.

Risk Management

Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material.Ensure public availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia)

Latitude of Action:

Partnerships and transversal collaboration

Develop and maintain a good working relationship with internal and external stakeholders

Role Impact:

Regulatory Environment influence

Actively follow the development and emergence of new regulatory requirements and regulatory intelligence, ensuring that the appropriate impact assessment and company strategy are delivered to the relevant stakeholders Lead Sanofi CHC RA active participation in local trade associations to influence the regulatory environment to drive growth in accordance with company strategy and purpose and global corporate positions

Innovation

Contribute and provide insight for innovation programs leading to innovative regulatory pathways to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategiesLead HA Interactions ensuring that all projects have clearly defined regulatory paths to deliver on the product vision and milestones are met leading to successful filings and approvals.

Scope:

The Regulatory Affairs Lead will lead the local CHC regulatory strategy and guidance to the local team ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment. Be a partner for local business to support the delivery of business objectives within the regulatory framework.

Qualifications/ Education & work experience

Minimum MS; Pharm D, MD, PhD or equivalent preferredRelevant experience in in Regulatory Affairs of at least 3 or 4 yearsKnowledge of local regulatory affairs regulation

Special Knowledge & Qualifications

Good understanding of the consumer healthcare and pharmaceutical industryKnowledge of CHC regulations and requirementExcellent command of English languageGreek language: native speaker

Additional Skills

Team collaborationAct for changeThink strategically and strive for resultsStrong interpersonal/communication skillsAbility to work in a matrix environmentBusiness acumen and customer orientationHigh standards of integrityAbility to develop strong networks and influence internal and external stakeholders

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, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!