Sanofi ist ein weltweites Gesundheitsunternehmen, das Menschen bei ihren gesundheitlichen Herausforderungen unterstützt. Mit unseren Impfstoffen beugen wir Erkrankungen vor. Mit innovativen Arzneimitteln lindern wir ihre Schmerzen und Leiden. Wir kümmern uns gleichermaßen um Menschen mit seltenen Erkrankungen wie um die Millionen von Menschen mit einer chronischen Erkrankung.
Mit mehr als 100.000 Mitarbeitern in 100 Ländern weltweit übersetzen wir wissenschaftliche Innovation in medizinischen Fortschritt.
Sanofi, Empowering Life.
</div>Key responsibilities
You will be in charge of the whole portfolio of our Consumer Health Care (CHC) business. Our portfolio is expanding and includes medicinal products, medical devices, food supplements and cosmetics.
You will propose and prepare submission strategies for new products. You will be the contact for Swissmedic and proactively propose interactions with regards to optimizing the success of the authorizations of our new products in Switzerland.
You will follow up the life-cycle of the assigned portfolio, by proposing strategies, and maintain the existing Marketing Authorizations by submitting labeling and CMC variations.
You will be included in the development and approval of promotional material, including digital material, and of websites.
You will be working very closely with the Business Unit and withGlobal Regulatory Affairs, in an international context, as well as with partner functions, e.g. Pharmacovigilance, Quality, Medical and Supply Chain, .
You will be working within a competent, professional and highly motivated team.
You will also have the opportunity to actively take part in innovative projects and in transversal projects.
Qualifications
University degree in Pharmacy or equivalent.
Experience of at least 5-10 years in Regulatory Affairs in CHC in Switzerland, including non-medicinal products (food supplements, cosmetics) and registration of new medicinal products.
Excellent understanding of the consumer healthcare and pharmaceutical industry
Experience with health authority interactions, especially with Swissmedic is required.
Expert knowledge of European and local swiss consumer healthcare regulations and requirements enabling innovative regulatory strategies including the increase of literacy in digital offers, partnering with Health Authorities (In-depth understanding of new scientific and regulatory trends)
You speak German and English or French and English (German and English will be preferred). In addition, Italian is a plus.
Good IT skills (e.g. office, SHARE, VeeVa Vault). Knowledge of eCTD is a plus.
Soft skills
Team collaboration & Ability to work in a matrix environment
Leadership and Decision making focused
Act for change and digital oriented
Think strategically and strive for results
Strong interpersonal/communication skills
You are agile, flexible, innovative, business orientated, analytic and synthetic thinking, teamwork oriented and able to work under pressure.
Fulltime position
Location
Rotkreuz
#LI-GSA
Diversity und Inklusion“ sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.
</div>Key responsibilities
You will be in charge of the whole portfolio of our Consumer Health Care (CHC) business. Our portfolio is expanding and includes medicinal products, medical devices, food supplements and cosmetics.
You will propose and prepare submission strategies for new products. You will be the contact for Swissmedic and proactively propose interactions with regards to optimizing the success of the authorizations of our new products in Switzerland.
You will follow up the life-cycle of the assigned portfolio, by proposing strategies, and maintain the existing Marketing Authorizations by submitting labeling and CMC variations.
You will be included in the development and approval of promotional material, including digital material, and of websites.
You will be working very closely with the Business Unit and withGlobal Regulatory Affairs, in an international context, as well as with partner functions, e.g. Pharmacovigilance, Quality, Medical and Supply Chain, .
You will be working within a competent, professional and highly motivated team.
You will also have the opportunity to actively take part in innovative projects and in transversal projects.
Qualifications
University degree in Pharmacy or equivalent.
Experience of at least 5-10 years in Regulatory Affairs in CHC in Switzerland, including non-medicinal products (food supplements, cosmetics) and registration of new medicinal products.
Excellent understanding of the consumer healthcare and pharmaceutical industry
Experience with health authority interactions, especially with Swissmedic is required.
Expert knowledge of European and local swiss consumer healthcare regulations and requirements enabling innovative regulatory strategies including the increase of literacy in digital offers, partnering with Health Authorities (In-depth understanding of new scientific and regulatory trends)
You speak German and English or French and English (German and English will be preferred). In addition, Italian is a plus.
Good IT skills (e.g. office, SHARE, VeeVa Vault). Knowledge of eCTD is a plus.
Soft skills
Team collaboration & Ability to work in a matrix environment
Leadership and Decision making focused
Act for change and digital oriented
Think strategically and strive for results
Strong interpersonal/communication skills
You are agile, flexible, innovative, business orientated, analytic and synthetic thinking, teamwork oriented and able to work under pressure.
Fulltime position
Location
Rotkreuz
#LI-GSA
Diversity und Inklusion“ sind in den Grundwerten von Sanofi verankert und spiegeln sich in unserer Arbeitsweise wider. Wir respektieren die Vielfalt unserer Belegschaft in Hinsicht auf ihre Herkunft, Erfahrungen und Lebensweisen. Wir erkennen die Bereicherung, die diese Vielfalt birgt, und fördern Inklusion sowie eine Arbeitsumgebung, in der diese Unterschiede sich weiter entwickeln können, zur Stärkung des Lebens unserer Mitarbeiter, Patienten und Kunden.