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Senior Regulatory Specialist, Site CMC

Posted 26 Mar 2024
Work experience
3 to 5 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

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Job Description

At Haarlem we have an exciting opportunity for a

Senior Regulatory Specialist, Site CMC

Regulatory Affairs

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Job description

The candidate will be part of our corporate Regulatory CMC organization and will support CMC Conformance within the Haarlem and Heist manufacturing site. The establishment of site CMC Conformance is a key component of our strategy to build effective linkage of the CMC RA organization with our production department.

Reporting to the Associate Director, Site CMC, the senior regulatory specialist role will support the conformance of our products with the approved Marketing Authorisations and will support regulatory submission activities associated with the site.

Main responsibilities

  • Core function – manage the interface between the Manufacturing site and Regulatory CMC to maintain product regulatory conformance. Specific responsibilities include:
  • Ensuring that the information included in filings is aligned to plant information and supports future compliance and maintenance
  • Ensuring that regulatory-impacting changes are correctly identified and assessed for regulatory impact. Work with other CMC teams to ensure that regulatory post-approval changes are prosecuted efficiently through to last market approval and implementation.
  • Ensuring that regulatory information is correctly maintained, updated and interpreted, using our Regulatory Information systems and tools
  • Working with site Quality, Technical and Supply chain functions to ensure that product is released in accordance with the relevant Global Marketing Authorisations

Other activities

  • Co-ordinates submission component authoring (mainly for post-approval CMC changes) with site SMEs and CMC product leads. Co-ordinates responses to BoH questions on submissions. Sources and provides technical data and reports, ancillary submission documents to support regulatory submissions and BOH questions.
  • Participates in major project teams where there will be significant regulatory impact, e.g. product transfer teams.
  • Ensures that BOH commitments are captured in site commitment tracking and are fulfilled
  • Supports BOH notifiable events and investigations
  • Supports BOH inspections
  • Drug Master File, Site Master File authoring / updates

Research & Development Division

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And we believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Your profile

  • The candidate must possess a relevant Bachelor’s degree or higher in science, (e.g. pharmacy, chemistry, biotechnology, microbiology, biomedical sciences etc.) with a minimum of 3 – 5 years of experience in the pharmaceutical industry in a regulatory, compliance technical or quality role.
  • Some experience of CMC regulatory affairs (3-5 years), ideally gained in a manufacturing environment or regulatory agency would be an advantage.
  • Exceptional candidates without direct CMC experience will be considered where they possess a significant technical and scientific background and they have prior experience of significant engagement with Regulatory CMC projects and Regulatory Agencies
  • The candidate must have a good understanding of and experience working with a busy commercial manufacturing organization.
  • He/she will demonstrate effective problem solving, understanding of regulatory strategies, excellent interpersonal skills, detail oriented, and able to prioritize multiple tasks.
  • Must have a proven ability to communicate effectively in both a written and verbal format.
  • Ability to influence and work both independently and collaboratively in a team structure.
  • Proven ability to work well under pressure

MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de…


MSD als werkgever
Keer op keer nieuwe uitdagingen aangaan, dat is wat bij je moet passen als je bij MSD aan de slag wilt. Want continu verbeteren is een van onze drijfveren. Dat geldt zowel voor werkprocessen als voor medewerkers. Gedrevenheid, teamwork en eigen initiatief zijn van groot belang. Bij MSD kun je je op allerlei manieren ontwikkelen. In de diepte, door je te specialiseren in je vak. Maar ook door jezelf te verbreden en door te groeien naar een leidinggevende functie. Internationaal of juist heel lokaal, er zijn talloze andere mogelijkheden om stappen te zetten in je loopbaan, te rouleren in functies of te groeien in je functie. Werken bij MSD is werken in een dynamische high tech omgeving van internationale allure, die toch sterk lokaal geworteld is in Oss, Haarlem en Boxmeer.

Pharmaceutical
Haarlem
5,600 employees