- Region Basel
- Art des Vertrags Temporär - Vollzeit
- Tätigkeitssektor Chemie / Pharma / Biotechnologie
As a preferred supplier for Roche Diagnostics in Basel, Switzerland, we are looking for a motivated personality as Technical Regulatory Affairs Manager (contract for 1 year, with extension if it is a fit for all parties) start date within 3 months. Remote/Home Office is possible.
In the role of Technical Regulatory Team Member (TRT), you are contributing to the development and execution of regulatory strategies, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups. The focus of the TRT is on enabling global CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle including dossier preparation.
The candidate will be part of the technical regulatory team focused on large molecules post-approval products. The team works in squads on one or more product. They are in charge of assessing regulatory change requests coming from the sites or from different global function: checking for discrepancies and following up on submissions if needed. The successful candidate will be working on content management: reviewing, writing, updating, ensuring overall alignment and make sure documents are up to standards.
- Be accountable for the development, communication and execution of sound regulatory strategies that meet global regulatory requirements and enable business objectives, including identification and communication of regulatory risks and development and execution of risk mitigation strategies in concert with technical functions.
- Be accountable for submissions of high quality CMC regulatory documents to health authorities in accordance with Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.
- Effectively manage regulatory changes throughout the product life cycle.
- Represent Pharma Technical Regulatory on cross-functional teams and work effectively with multiple disciplines and personalities.
- Contribute to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.
- Be accountable to keep abreast of regulatory procedures and changes.
- Contribute to driving efficiency by assertively simplifying, taking risk and cutting out waste.
- Min Bachelor, Master or Doctor preferred in Life Science or a law degree with pharma industry
- Min 5 y in Technical Regulatory Affairs
- Hands on experience working on CMC
- Experience working on large molecules
- Experience working within post-approval lifecycle and regulatory submissions
- Possesses the ability to prioritize and work effectively both within a team environment and independently.
- Ability to influence teams and functions in defining global technical regulatory strategies.
- Takes ownership, is decisive, and uses a network and creativity to solve problems and progress programs and projects.
Nice to have
- Experience working in and agile environment
- Experience working for a large pharma company
- Agentur GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
- Veröffentlicht am 24. März 2021
- Berater-in Marijke van Engelenburg