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- Posted 09 December 2022
- Job type Permanent
- Contact NameDavid Skinner
BioTalent are partnered with an exciting company to assist their search for a newly created Regulatory Affairs Manager on a permanent basis as part of their ongoing growth plans.
- Maintain the approved dossiers of the lifecycle of the products
- Ensure that Regulatory procedures and records with respect to CMC / Quality are in compliance with applicable regulations and standards
- Prepare administrative documentation on time and Module 1 documentation for regulatory submissions / variations as well as provides support to CMC writing for initial MA submission in various regions.
- Ensure that regulatory variations are accurate and verifiable against source documents to confirm compliance and traceability
- Prepare submissions for new markets
- Participate in expert discussions with different stakeholders’ prior approval and support by answering questions during the approval process
- Maintain the Quality System for Regulatory Activities
- Collaborate closely with external service providers (e.g. publisher or CMC writing) on Regulatory Affairs aspects
- Support Senior Management and Line Manager in all Regulatory Affairs aspects
- Collaborate with Regulatory Affairs functions within and outside of the company
- Interact with Health Authorities on Regulatory Affairs aspects of the company
- Manage Change control system and coordinate information to all relevant stakeholders on time
- Assure post marketing surveillance regarding pharmaceutical legislation and guidance in Switzerland
Qualifications and skills:
- You have a cooperative, self-motivated and pro-active mindset.
- You combine excellent planning and execution skills with the ability to work effectively in international matrix organisations.
- University degree / state examination in pharmacy or other natural sciences
- Proven track record of 4+ years in the pharmaceutical industry in Life Cycle Management internationally with at least 3 years of GMP/GDP experience in a regulatory function, preferably as Regulatory Affairs Project Manager
- Experience of working in different regulatory regions
- Sound knowledge of EU, US and CH GMP/GDP regulations, in quality system requirements, as well as from biopharmaceuticals
- Good knowledge of eCTD structure and its compilation
- Ideally you have already submitted new applications and maintained dossiers over their lifecycle
- Fluent in English