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Senior Regulatory Manager – 4914 LBD
Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Senior Regulatory Manager, for a contract role to be based in Basel Area. An ideal candidate would have 8+ years in Regulatory product development and portfolio transformation activities and have advanced degree in scientific education.
- Regulatory support of the portfolio transformation team, especially divestments (focus data collection, implementation).
- Track progress of assigned projects, including timelines, dossier deliveries. Alert project team and RA GDD management to risks, issues and achievements.
- Facilitate communication between regulatory associates and cross-functional project team members.
- Lead or participate in multidisciplinary teams focusing on identifying gaps, escalating concerns and supporting and driving continuous improvement and management initiatives.
Key Performance Indicators (KPIs)
- 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.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Minimum of 8 years in Regulatory product development and portfolio transformation activities. Proven expertise in project management.
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Desirable: Advanced degree in science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent.
- A good understanding of pharmaceutical technology, product life cycle management and the drug development process.
- 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 and international environment and team player.
- Proven record of accomplishment of successful risk assessment.
- Advanced interpersonal skills. Strong conflict-management skills. Open communicator and High level of organizational awareness.