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Regulatory Affairs Manager - All Gender

CDI
Gentilly
Salaire : Non spécifié
Télétravail non autorisé
Éducation : Bac +5 / Master

Sanofi
Sanofi

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Le poste

Descriptif du poste

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

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.

About the opportunity

Within Scientific Affairs France/Sanofi CHC in France, we are looking for a Regulatory Affairs Manager for a diversified portfolio of OTC core products in Cough and Cold, Digestive and Allergy categories.

You will be in charge of the strategic and operational regulatory affairs activities for a portfolio of core local brands including development and marketed products. You will also support the regulatory strategy for the global brands within the categories.

You’ll be in charge of actively & collaboratively shaping the regulatory selfcare environment in France.

You will directly report to the Scientific Affairs France Category Lead managing both regulatory and medical activities for these categories.

About growing with us

As regulatory portfolio owner, you will

  • Lead the development and the execution of the regulatory strategies in France for the assigned portfolio in accordance with the European and French guidelines in collaboration with EU and Global Scientific Affairs teams

  • Develop and validate the promotional materials to professionals and consumers to ensure compliance with internal & external guidelines/standards

  • Ensure the differentiation of the assigned portfolio vs competitors in identifying new claims

  • Guarantee the sustainability of the assigned portfolio through various initiatives

  • Lead direct interfaces with Competent Authorities

  • Actively participate to French selfcare Trade Associations

As regulatory core brand member, you will

  • Actively contribute to provide regulatory insights, to help drive and shape the brand strategy

  • Provide registration strategy and intelligence for due diligence and business development initiatives

  • Support commercial teams

About you

  • Pharmacist with a master in regulatory affairs

  • Minimum 2 years in regulatory affairs

  • Good knowledge of the European and the French regulations on OTC and Medical Devices

  • Experience in Promotional Materials Validation

  • French native speaker, and good level in English

  • Expert in managing matrix teams and partnering with cross functional teams such as Marketing, Consumer Market Insights, Industrial Affairs and Medical Affairs

  • Demonstrated success in developing regulatory strategies

  • He/she will bring creative & innovative ideas to the table to enable category strategies

  • He/she will contribute in shaping the external regulatory environment

Other Personal Characteristics

  • High standards of integrity and quality

  • Dedicated and persuasive “can-do” attitude

  • Self-motivated; entrepreneurial spirit

  • Organizational savvy; be able to work in a highly matrix structure

  • “Think out of the box”

Location:Gentilly (Neuilly-sur-Seine in 2023)

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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