Regulatory Manager

Posted 25 November 2021
Job type Limited
DisciplineScienceLife Sciences

Job description

For our client, a big pharmaceutical company with headquarters in Basel, we are looking for a

Regulatory manager

Your Responsibilities:

  • Regulatory support of the portfolio transformation team, especially divestments (focus data collection, implementation), production transfers and portfolio rationalization (pruning, deregistration)
  • Track progress of assigned projects, including timelines, dossier deliveries, HA approvals. Alert project team and RA GDD management to risks, issues and achievements.
  • Facilitate communication between regulatory associates and cross-functional project team members (BD&L, CMC, NTO, legal, RA in the countries).
  • Lead or participate in multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives.
  • Data/business analytics - driving/reporting performance metrics (methodology, design, tracking)
  • Recognized by external and internal RA GDD customers as a trustworthy, competent, and reliable partner with a good overview of the project portfolio and regulatory requirements for production transfers.
  • Consistent record of strategies and processes devised and implemented successfully to deal with new developments, and rolled out to departmental staff, reflecting sound risk management and appropriately considering all stakeholder's need.
  • Reliable, timely, accurate and proactive communication of general of project specific issues to key stakeholders as appropriate.

Minimum requirements:

  • 5-8 years in Regulatory portfolio transformation activities (divestments, Tech Transfers)
  • Minimum Master degree in Life Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
  • Fluency in English - written and spoken
  • Proven expertise in project management.
  • A good understanding of pharmaceutical technology (previous CMC experience - as advantage) and product life cycle management.
  • Proven record of accomplishment of early recognition of potential regulatory issues, distilling complex situations, sound risk assessment and overcoming hurdles.
  • Ability to work in cross-functional (BD&L, CMC, NTO, legal) and international environment.
  • Strong team player (communication, collaboration)
  • Proven record of accomplishment of successful risk assessment.
  • Advanced interpersonal skills. Strong conflict-management skills. Open communicator.
  • High level of organizational awareness.
  • Data analytics/Data management experience - desired an additional advantage!

Workplace: Basel
Workload: 100%
Start Date: 01.01.2022
Duration: 12 month

Your Application
Please apply online. For further information about the position, please contact your Kelly recruiter, Mr Judith Atgé Martin (+41 61 270 80 16).