Regulatory Affairs Manager

Regulatory Affairs Manager

Sanofi

Baar, Switzerland

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 with Global 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.

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© EuroJobsites 2020

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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