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.

Key Responsibilities:

• 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