Regulatory Affairs Lead

Regulatory Affairs Lead Spain

Barcelona, Spain

About the role:

Ready to push the limits of what’s possible? Join Sanofi CHC in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.

This role reports to the CHC Regulatory Affairs WE HEAD, the Regulatory Affairs Lead ES is responsible for leading/ support the local CHC Regulatory 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.

Main responsibilities

Talent and Leadership

• Help to define local RA priorities in line with business and Science priorities and agreed with the RA WE Head.

• Collaborate in the definition/ follow up of the Regulatory budget with the RA WE Head (local scopes). (TBD how this will be managed)

• Provide input to the RA WE Head about optimal resource capacity for performing required regulatory activities.

• Ensure high quality submissions within timelines agreed with GRA, business and/or health authorities.

• Establishing effective partnerships and transversal collaboration

• Develop and maintain a good working relationship with internal and external stakeholders, in line with Sanofi’s CHC values

• 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 requirements

• Ensure local implementation of GRA mandatory SOPs and training

• Ensure quality and compliance of local regulatory activities in line with corporate regulatory affairs, national regulations.

• Ensure maintenance of regulatory databases.

• Health Authority Interactions:

• Act as interface between the company and local regulatory authorities in Spain.

• Build credible relationships with health authorities in ES, making Sanofi CHC a recognized partner with the agencies and providing regulatory thought leadership

• 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 association in Spain, to influence the regulatory environment to drive growth in accordance with company strategy and purpose and global corporate positions

• Portfolio Management:

• Champion the review and approve promotional and non-promotional materials ensuring their competitive position and compliance with local regulations, code of conduct and internal guidelines. As local process owner, lead review process with the responsible functions in the country fostering the use of CDP.

• Lead the management of the local maintenance activities and ensure compliance of the marketed product portfolio

• Lead development of the Local Regulatory strategies for geographical extensions

• Manage with other functions the preparation of local dossiers for the products under development and territory extensions

• Lead development of local strategies and preparation of OTC switches

• Ensure that best efforts are provided to get timely approvals of dossiers

• Lead the regulatory due diligence for local BD opportunities, collaborating with other relevant functions and providing strategic recommendations to enable appropriate portfolio decision making

• Provide 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.

• Innovation:

• Contribute and provide insight to GRA for innovation programs leading to innovative regulatory pathways to drive competitive positioning, maximize chances of approval and identify opportunities, regulatory risks and mitigation strategies

• Lead 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

• Risk Management:

• Co-ordinate the local health authority approval and implementation of risk management plans and DHPCs and educational material when applicable

• Ensure public availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia)

Why Choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare