Regulatory Affairs ManagerLocation: Stockholm, Sweden or Helsinki, FinlandHybrid working policy-at least 3 days in the week onsiteThis is a fixed term contract for maternity leave replacement

About the job

Sanofi is an innovative global healthcare company headquartered in Paris, France with one purpose: Chase the miracles of science to improve people’s lives. The company is focused on accelerating development to deliver breakthrough medicines and vaccines to patients, delivering excellence though Diversity.

We are dedicated to making a positive impact on the lives of the patients and families we serve, and we accomplish our goals through world-class research and with the compassion and commitment of our employees.

Main responsibilities:

Manage/facilitate applications, and responses for assigned new and established products to Nordic regulatory authorities’, to the highest possible standards within agreed time frame to facilitate fast  and optimal approvals.Ensure timely implementation of updated Company Core Safety Information in local labelling.Ensure timely creation and update of packaging material for assigned products in accordance with  business needs and regulatory requirements.Ensure implementation and maintenance of accurate information for assigned products in national  drug register (LiiV) and product catalogue (FASS).Maintain close collaboration with corporate RA functions and North Europe RA colleagues.Establish and maintain effective liaison with the regulatory authorities and relevant Sanofi functions, particularly business, supply chain, safety, quality, and medical departments.Monitor and report on regulatory developments and changes that may impact the company's products and business.Archive in a timely manner all relevant documents and update local and corporate electronic archives and data bases.Support market access concerning tender business.Support the global CTA team in local interactions and local CTA reg intelligence when applicable Support the Regulatory reviewer of promotional material for assigned products when needed.To support the marketing team’s objectives and be a part of the business strategy by providing Strategic RA advice and obtain and maintain relevant product/project/therapeutic area knowledge about the BU portfolio.Veeva Vault Super User: o act as local Veeva expert ready to assist co-workers with use of the Veeva Vault application o function as a “first responder” Veeva support person for unit staff o attend trainings and updates and completing own competency continually o take the lead in education and competency checkoff of co-workers continually and for new hires o participate in testing or pilot projects of the application as applicable.

About youGood knowledge in Swedish or Finnish and English languages; written and oral form.10 years’ experience in the Regulatory field.Structured and Accurate.Good communication skills.Proactively seeks information about project/product activities.Good co-operations skills.Project management skills.People management skills.IT and computerized system skills.Works independently to plan, structure and coordinate assignments.

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.Drive implementation science, powerful crowdsourcing and open innovation , discovering the ways to bring science to live faster , contributing to a patient first mindset.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

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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!