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Life Sciences Stellen Basel
EDP 25 Jahre Jubiläum

Global Regulatory Affairs Manager (m/f/d), 100%

Temporärstelle
Einritt: asap
Stelle: Life Sciences
Art: Temporärstelle

Are you ready for the next challenge? As the Global Regulatory Affairs Manager for Vitamins, you will be part of a cross-functional team of around 10 employees, based near Basel, Switzerland. The activities linked to the position are highly complex due to the dynamics of the global market and changing regulatory environments. Your responsibility will encompass the integration of the Marketing and Sales, plans into your regulatory strategy program and its global roll out in cooperation with the regional teams. You will be part of a highly professional and motivated team. The vacancy is available as per agreement, the sooner the better.

asap

#Pharma #RegulatoryAffairs #TopJob #YourNewJob

Our customer, a pharmaceutical company based near Basel, needs reinforcement. For a temporary employment (Duration: 9 months), we are looking for a

Global Regulatory Affairs Manager (m/f/d), 100%

Major accountabilities:

  • Lead the joint efforts for the development of the global product approval strategy for pharma, food, and feed in a timely and accurate manner.
  • Manage the Dossier preparation (e.g. DMFs, CEPs, Core Dossiers) for product approval in collaboration with R&D, Product and Project Management, 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 DNP products.
  • Monitor and report modification of the changing regulatory framework and environment, and assess their impact on the business
  • Lead the development of 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 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.

Background:

  • University degree in chemistry or natural sciences life sciences
  • Several years of experience in Regulatory Affairs and/or Quality Management/Production background, preferably in Vitamins and APIs
  • Interdisciplinary knowledge in the areas of Analytics, Chemistry and production process, Biology and Toxicology (solid up to in-depth).
  • 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

For questions

… please contact Mr. Renato Imboden by phone on 061 269 90 60

Our current Job offers: www.edp-basel.ch / www.stellen-basel.net

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