Regulatory Compliance Expert (m/f/d)

Posted 15 Feb 2024

Corsier-sur-Vevey, Vaud - Switzerland

Req Id 270948

 

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.

 


You will ensure CMC dossiers of the site commercial and development products are consistent and compliant with the site activities and will coordinate the site review of quality (Quality/CMC) sections for clinical trials applications or worldwide submissions. You will also ensure the site right to operate through successful inspections from Health Authorities and audits from partners and the global functions.

 

Your role:

Site Regulatory compliance activities:

  • Ensure Quality/CMC consistency and compliance by liaising with the Global Regulatory Affairs department. You will support the establishment of Regulatory reporting (e.g. Annual Reports) and Regulatory Affairs requests (e.g. renewals process, statements, GMP certificates).
  • be involved in the Change Control Proposals (CCPs) from a regulatory perspective.
  • Provide the regulatory status overview for products portfolio to the Qualified Person of the site in the frame of product disposition process.

 

Inspection Readiness activities:

  • Lead the site Quality inspections readiness program, from notification by the inspection body until approval of the CAPA plan
  • Central member of the audit/inspection hosting team
  • Coordinate and follow-up the definition and execution of CAPA plans

Who you are:

•Degree in a Life Science or related discipline (minimum MSc or equivalent degree), higher degree preferable (e.g. PhD in a scientific discipline)

•You have at least 5-7 years of experience in the pharmaceutical industry

•You have at least 5 years of experience in global CMC regulatory affairs, and quality assurance / compliance, inclunding experience in inspection readiness.

•Experience with life-cycle management activities in at least two regions (e.g. Europe, USA, or International)

•Experience in preparation and management of regulatory documentation, normally a full international submission (new product application) or a large variation

•Good knowledge in biotechnological sciences, manufacturing of biologics and related regulatory guidelines (cGMPs, 21 CFR, etc.)

•​​​​​​​​​​​​​​Excellent written and spoken communication skills in French and English

 



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!


US Equal Employment Opportunities

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.


Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

Apply Now

Join our Talent Zone

You haven't found quite the right job yet? Join our Talent Zone and stay in touch with us. Be the first one to learn about our new career opportunities and events.

Tell us about yourself and let our Talent Advisors help you find your next career opportunity.