Associate Manager Regulatory CMC

☞ Merck Group

Visualizza: 192

Giorno di aggiornamento: 29-03-2024

Località: Aubonne Vaud VD

Categoria: Pianificazione / Progetti Produzione / Funzionamento

Industria: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing

Posizione: Entry level

Tipo di lavoro: Full-time

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Contenuto del lavoro

Your role:

You will be responsible for driving and supporting all global CMC submission activities (incl. planning, authoring, reviewing, coordination, submission) for commercial biotech products and projects worldwide. In this role you will develop the relevant global regulatory CMC life cycle strategy and represent Global Regulatory CMC on cross-functional project teams and maintain collaborative partnership with stakeholders such as technical CMC-, quality-, supply- and regulatory affairs functions.

This encompasses the responsibility for authoring and reviewing high-quality CMC documentation for Health Authority submissions, while ensuring technical congruence and regulatory compliance. Beyond this you will identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines. In addition, you will perform regulatory assessments for changes.

Who you are:

  • University degree in Life Sciences such as Biochemistry or Biotechnology (minimum MSc or equivalent degree)
  • Minimum of 1 year of pharmaceutical industry experience in either CMC regulatory compliance and/or a CMC technical role (e.g. in regulatory affairs, quality control, analytical development or manufacturing / process development)
  • Thorough understanding of biotechnological processes such as upstream/downstream processing
  • Experience in preparation and management of regulatory CMC documentation and the management of the regulatory life-cycle management (e.g. annual reports, renewals, variations).
  • Practical Experience with Regulatory Information Management Systems and Trackwise
  • Sound understanding and or relevant global pharmaceutical legislation
  • Good project, time management and planning skills
  • Ability to work in teams
  • Attention to details
  • Ability to think strategically
  • Excellent written and spoken communication skills in English (knowledge of other European languages such as French, Italian or German is an asset)

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

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Scadenza: 13-05-2024

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