Job details

Regulatory Strat. Coordination Lead & Resp Person

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Career level
Senior (5-10 years), Executive (>10 years)
Employment type
Full time
Spoken languages
English - Advanced
* all languages are compulsory
Address
Number of vacancies
1

CHC - EU Regulatory Strategic Coordination Lead & Responsible Person Deputy Romania

About the Opportunity

Join Sanofi Consumer Healthcare  Romania as CHC - EU Regulatory Strategic Coordination Lead & Responsible Person Deputy Romania.

The main mission is to:

  • fulfill all the activities provided for Responsible Person in GDP and management of products complaints, quality events and quality alerts in the absence of the RP/CQH

  • manage the portfolio of European products (medicinal products (chemically defined and herbal), medical devices, food supplements and cosmetics if applicable) under development and marketed products

About Sanofi

At Sanofi Consumer Healthcare (CHC), we have one shared purpose - we work passionately, every day, to ‘serve healthier, fuller lives’. Our marketing philosophy is driven by this purpose and everything we do is centered around people – our consumers, our customers, healthcare professionals, and our employees – across the world.

About growing with us

Key accountabilities:

In the absence of Responsible Person/CQH

  • Ensure GDP compliance of wholesale distribution activities by the corresponding Wholesale Distribution License in full compliance with GDP requirements

  • Ensure that is implemented and maintained a quality system in distribution activities, through direct collaboration with Responsible Person and other personnel involved in distribution activities

  • Focus on management of authorized activities, on the accuracy and quality of records, but not limited to them (. temperature records, reception, documents, products deliveries, etc.)

  • Ensure that the public service obligations for affiliate are met in compliance with good distribution practice

  • Keep a clear evidence of the delegated tasks

  • Secure delivery of safe, efficient, quality products, information & services to ensure patients/customers safety and act as Quality Business partner to support business priorities

  • Point of contact in front of the Competent Authorities for any product quality/technical and GDP-related matter

Ensure portfolio management Excellence & Science Strategies:

  • Develop scientific strategy and provide expertise with within project/product teams for products under development and/or marketed regional products

  • Define, coordinate, and contribute to the preparation of the dossiers and response documents to Health Authority questions within the Science organization for regional and defined multi-regional products/projects

  • Direct Health Authority interaction and communication for European procedures, including Scientific advice

  • Provide Science support to policy, external trade association collaboration, and risk management. Follow regulatory changes, competitors’ status and assess potential impact on daily activities and project strategy

  • Be accountable for the maintenance of the existing European portfolio, managing the maintenance activities such as renewals, variations, benefit/risk assessments, referrals, discontinuation process, PRAC signals, PBRER/PSUSA/DSUR, etc.

  • Steer operational excellence coordination and governance within the region to ensure adherence to internal deadlines and KPIs, . monthly validation of events of worldwide CHC medicinal products

About you

Qualifications/ Education & work experience

Education

  • Faculty of Pharmacy. Professional certification according to local regulations

Required knowledge and/or experience

  • Minimum 5-7 years in the Consumer Healthcare or Pharmaceutical industry, in Regulatory Affairs (global, regional, or local)

  • Minimum 1 year of pharmaceutical experience in similar position of RP/RP Deputy/Quality, with in-depth knowledge of the regulatory and legal aspects of the business, pharmaceutical legislation and quality standards

  • Project management experience in the pharmaceutical industry or in an international regulatory environment

  • Comprehensive expert knowledge of and operational expertise in regional pharmaceutical regulations of medicinal products and medical devices as well as food supplements

  • Ability to evaluate impact of new regulations within the drug development environment and to lead discussions of the requirements and its impacts within submission teams

  • Fluent spoken and written English and Romanian

Inspire your Journey: what Sanofi can offer you:

  • An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team

  • An attractive, market-oriented salary aligned with your qualifications and including social benefits above average (. company pension plans, health management)

  • An individual and well-structured introduction and training when you onboard

  • You can create your own career path within Sanofi. Your professional and personal development will be supported purposefully

  • As a globally successful and constantly growing company, Sanofi provides international career paths as well

This is our Sanofi. Discover yours.

Own your future. Make your move!

#LI-EUR

We are proud to have been awarded Global Top Employer 2021.

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.