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Global Regulatory Affairs Manager PRQM Vitamins (m/f/d) (EN)

[11920]
Regulatory Affairs, Regulatory Submission Management, Vitamins

Job title: Global Regulatory Affairs Manager PRQM Vitamins (m/f/d) Industry: Pharma Skills: Regulatory Affairs,Regulatory Submission Management,Vitamins Start of project: 01.11.2022 Duration of the project : 6 months' Project volume: 1008 Stunde(n)  Location: Switzerland Tasks:   ·• Lead the joint efforts for the development of the global product approval strategy for feed, food and also pharma in a timely and accurate manner. ·• Manage and support the food and feed submissions (i.e. new registrations, renewals of authoriza-tions or line extensions) in certain regions or countries ·• Dossier preparation (e.g. DMFs, CEPs, Core Dossiers) and support for product approval in collab-oration with R&D, Product and Project Management, global and regional Regulatory Affairs based on the global Regulatory Affairs strategies of DNP. Coordinate the submission of dossiers to the regional authorities and follow up on the approval process. ·• Work with Product Management and production sites to ensure regulatory compliance of NP products. ·• Monitor and report modification of the changing regulatory framework and environment, and as-sess their impact on the business ·• Lead the development of company opinions in the area of Regulatory Affairs ·• Develop SOPs, work on and/or select appropriate regulatory platforms & applications (software solutions), as appropriate to specific issues. ·• Contribute to the development and maintenance of registration status & planning platforms. Highly contribute to the Regulatory Affairs team performance by taking leadership in development and maintenance of efficient RA tools (e.g. company store) processes and coaching of employees and junior colleagues. ·• Support Total Quality Management for the product-specific aspects (e.g. specifications) in customer Quality agreements, as needed. ·• Support issue management related to product quality, e.g. impurity complaints, in close cooperation with all internal functions (e.g, QA, Marketing & Sales, Product Management) and represent Regulatory Affairs. ·• Responsible for global or regional representation, networking and shaping activities, where applicable. ·• Support for global PIB document creation, update and maintenance. Qualifications:   ·• University degree in chemistry or natural sciences life sciences ·• At least 3-5 years of experience in Regulatory Affairs and/or Quality Management/Production back-ground, preferably in Vitamins and APIs ·• Strong persuasive personality, but able to balance and compromise different opinions ·• Strategic and solution-thinking skills ·• Precise working style, persistence in pursuing objectives ·• Open-minded and good team working abilities ·• Fluent in written and spoken English, German and any other language an asset

Job title: Global Regulatory Affairs Manager PRQM Vitamins (m/f/d)
Industry: Pharma
Skills: Regulatory Affairs,Regulatory Submission Management,Vitamins
Start of project: 01.11.2022
Duration of the project : 6 months'
Project volume: 1008 Stunde(n) 
Location: Switzerland

Tasks:

 

  1. Lead the joint efforts for the development of the global product approval strategy for feed, food and also pharma in a timely and accurate manner.
  2. • Manage and support the food and feed submissions (i.e. new registrations, renewals of authoriza-tions or line extensions) in certain regions or countries
  3. • Dossier preparation (e.g. DMFs, CEPs, Core Dossiers) and support for product approval in collab-oration with R&D, Product and Project Management, global and regional Regulatory Affairs based on the global Regulatory Affairs strategies of DNP. Coordinate the submission of dossiers to the regional authorities and follow up on the approval process.
  4. • Work with Product Management and production sites to ensure regulatory compliance of NP products.
  5. • Monitor and report modification of the changing regulatory framework and environment, and as-sess their impact on the business
  6. • Lead the development of company opinions in the area of Regulatory Affairs
  7. • Develop SOPs, work on and/or select appropriate regulatory platforms & applications (software solutions), as appropriate to specific issues.
  8. • Contribute to the development and maintenance of registration status & planning platforms. Highly contribute to the Regulatory Affairs team performance by taking leadership in development and maintenance of efficient RA tools (e.g. company store) processes and coaching of employees and junior colleagues.
  9. • Support Total Quality Management for the product-specific aspects (e.g. specifications) in customer Quality agreements, as needed.
  10. • Support issue management related to product quality, e.g. impurity complaints, in close cooperation with all internal functions (e.g, QA, Marketing & Sales, Product Management) and represent Regulatory Affairs.
  11. • Responsible for global or regional representation, networking and shaping activities, where applicable.
  12. • Support for global PIB document creation, update and maintenance.

Qualifications:

 

  1. University degree in chemistry or natural sciences life sciences
  2. • At least 3-5 years of experience in Regulatory Affairs and/or Quality Management/Production back-ground, preferably in Vitamins and APIs
  3. • Strong persuasive personality, but able to balance and compromise different opinions
  4. • Strategic and solution-thinking skills
  5. • Precise working style, persistence in pursuing objectives
  6. • Open-minded and good team working abilities
  7. • Fluent in written and spoken English, German and any other language an asset

map Schweiz date_range 01.11.2022 update Temporary
Direct contact

Moritz Janssen

Recruitment Consultant
mail m.janssen@aristo-group.ch
phone +41 44 274 39 00


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