Regulatory Compliance Expert

Vor 3 Tagen

Aubonne Vaud, Schweiz Merck (Schweiz) AG Vollzeit

 

Work Your Magic with us  

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

 

As an integral member of our Quality Unit, you will be accountable for change control assessment, compliance of manufacturing activities vs regulatory filing, provision of regulatory documents and regulatory intelligence and local expertise in RA. 

 

Your role : 

 

  • Lead critical SRC topics and SRC related projects
  • Provide Regulatory expertise for handling of major Regulatory topics to the SRC team and the site representatives.
  • Ensure alignment of local manufacturing activities and GMP documents with regulatory filings.
  • Coordinate the provision of regulatory deliverables to support regulatory submissions and Answers to Objections.
  • Responsible of product portfolio for Lifecycle management activitie and for some Technical regulatory writings.
  • Provide local expertise in compliance and CMC regulatory affairs and constitute the respective sites local point of contact for Merck Serono Regulatory Affairs CMC and for Health Authorities.
  • Responsible for site manufacturing registration renewal(s), provision of related Health Authorities certificates.
  • Responsible for artwork release in Webcenter as Site QA (SQA).
  • Maintenance of the Site Master File.

 

Who you are:

  • Biologist, pharmacist or other Life Science-related discipline, you have a relevant experience in biotechnological manufacturing
  • Training or education in regulatory, you have 2 to 5 years’ experience in interaction with regulatory agencies and posse
  • Fluently spoken and written English and French. A third European language would be an advantage.
  • Good editorial and communication skills
  • Organisation, structure and coordination have no secret for you 
  • You are known for your ability to be purposeful, result-driven and collaborative. 

 

 


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress
 
Apply now and become a part of our diverse team

 

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