Position: Associate

Job type: Full-time

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Job content

DSM – Bright Science. Brighter Living.™Royal DSM is a global science-based company active in health, nutrition and materials. By connecting its unique competences in life sciences and materials sciences DSM is driving economic prosperity, environmental progress and social advances to create sustainable value for all stakeholders simultaneously. DSM delivers innovative solutions that nourish, protect and improve performance in global markets such as food and dietary supplements, personal care, feed, medical devices, automotive, paints, electrical and electronics, life protection, alternative energy and bio-based materials. DSM and its associated companies deliver annual net sales of about 10 billion with approximately 25,000 employees. The company is listed on Euronext Amsterdam. More information can be found at www.dsm.com.

DSM Pentapharm, part of the nutrition cluster of the DSM group has a long-standing tradition as an innovative and reliable supplier of active ingredients for the personal care, pharmaceutical and haemostasis diagnostics industries.

As Regulatory Manager, you are responsible for managing and coordinating regulatory and strategic activities to company submissions (Pharma and IVDD, IVDR). This position will report to Head of Quality & Regulatory .

This position is responsible for managing and coordinating regulatory and strategic activities to company submissions (Pharma and IVDD, IVDR). This position will report to Head of Quality & Regulatory.

Tasks:

Your responsibilities will include:
  • Provide regulatory and strategic management to company submissions (Pharma and IVDD, IVDR)
  • Liaison with Regulatory Authorities (EU, US, China, Japan)
  • Effectively address regulatory issues that may surface during regulatory reviews and prepare and facilitate preparation of responses to Authorities in various countries worldwide
  • Responsible for development and implementation of the Regulatory Strategy and Risk Documents
  • Provide regulatory and strategic input on: development concepts and documents (e.g. dev plan, CTA/IND, briefing books, dossier documents); clinical study protocols and protocol amendments
  • Convey critical knowledge, especially relating to assigned products to alleviate or reduce regulatory impacts and costs.
  • Comply with applicable SOPs, GOPs and WIs
Education and Experience:
  • BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, Ph D, PharmD) preferred. Alternatively several years of regulatory or other relevant industry experience
  • Fluent English required (oral and written)
  • At least 3 years of relevant regulatory experience in Pharma and /or IVD
  • Good understanding of regulatory requirements for drug development and IVD, clinical studies, dossier filings worldwide
  • Experience in HA negotiations in different regions (EU, US, China, Japan)
  • Strong interpersonal skills, team player
.
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Deadline: 05-05-2024

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