CHC Regulatory Affairs Manager

CHC Regulatory Affairs Manager

Sanofi

Warsaw, Poland

About the opportunity

We are looking for a member of the Scientific Affairs Team, which includes Regulatory Affairs , Medical Affairs PV and Quality. As Regulatory Manager, you will be responsible for the registration/notification and maintenance of marketing authorizations for medicinal & other products. In addition to your daily duties, you will have the opportunity to shape both your future and the future of the entire team .

About growing with us

You will be responsible for:

  • Performance of registration, renewal and post-authorisation variation processes assigned products on the whole life in accordance with the applicable law.
  • Providing regulatory support at the product launch stage and in the creation of business strategies.
  • Delivering data on local regulatory conditions (task forces, workshops, web meetings with Global Functions).
  • Ensuring proper management of regulatory processes in line with business needs. Coordinating the implementation of any required packaging changes for drugs, and work with the other process participants to ensure continuous availability of products on the market.
  • Working with other global functions in the performance of business assignments: Medical, PV, Communication, Public Affairs, Marketing, Logistics, Legal, Quality, manufacturing sites, delivering regulatory data and expertise.
  • Identification and assessment of regulatory opportunities and risks associated with corporate projects evaluated (business development, registration strategy, due diligence).
  • Contributing to the proper reimbursement workflow by delivering the required regulatory data and registration dossier, as well as consistent cooperation with Public Affairs in the preparation of reimbursement applications.
  • Supporting CHC Poland & Zone CHC Head Eastern Europe in the development of uniform processes, optimization of regulatory activities by cooperating with managers and other colleagues; sharing knowledge on regulatory processes and projects led. Implementing new work processes and tools, and evaluating their performance.

About you:

  • A minimum of 5 years of work experience in working in a similar position in the pharmaceutical industry with proven successes
  • Master degree in the field of pharmacy, medicine, biology, chemistry or related
  • Good knowledge of Polish and European regulations in the field of pharmaceutical law,
  • Good understanding of the issues of quality and safety of pharmacotherapy and the ability to manage priorities,
  • Strong organizational competences, excellent attention to detail,
  • Strong problem solving skills, excellent communication and project management skills
  • Proven team management work experience
  • Very good command of the English and Polish language,

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© EuroJobsites 2021

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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