Regulatory Affairs***Option Suisse*** GLOBAL REGULATORY CMC biological
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Regulatory Affairs***Option Suisse*** GLOBAL REGULATORY CMC biologicals Liaison / Assoctiate Director *** 160,000 CHF (Swiss Francs)
Location: Switzerland, near Laussane
This is a great role for many reasons… the Location, the people, the projects, the autonomy, the salary, the package and the potential. Join one of fastest growing Biotechnology comanies receive a great all round package with an amazing salary, high, but achievable bonus and complete and comprehensive benefits package.
you will matrix manage/lead a team of 8 (including regional liaisons) in a Global role for all major regions including EU, US, LatAm, Asia, emerging markets etc. with responsibility for managing International and new country MAA's (including one scheduled for China) and lifecycle activities around major EU and International Variations, site transfers & drug substance changes.
This role will give you: • Global responsibility, including the US • MAA leadership for CMC globally
• Team leadership for 8 regulatory professionals, up to senior manager level • Full Strategic input on Global market expansion projects
Formulate, lead and drive regional and/or global CMC regulatory strategy for assigned products/projects with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance Lead, implement and drive CMC submission activities (planning, review, coordination, submission) for assigned projects/products. Make quality regulatory decisions as necessary, balancing risks and benefits. Represent Regulatory CMC in interdisciplinary regulatory and technical project teams. Establish and maintain a single point of contact with internal and external partners and customers for all communication on development projects and marketed products. Establish and maintain sound working relationships with partners and customers. Lead cross-functional Health Authority response teams for assigned development projects / marketed products, as appropriate.
Several years of experience in regulatory preferred. Excellent working knowledge/experience in regulatory submissions and approval processes for New Biological Entities (NBE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues and requirements. Proven track record in successfully leading/working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects.
Benefits: FULL RELOCATION, strong package, very low tax and a bonus.
If you wish to apply for this role, please send your CV with a covering note to or alternatively, to have a confidential discussion about this or other potential roles or career options, call Theo Moore or Matt Greig in the London office on (0). _____________________________________________________________________________________________
Advanced Regulatory is a division of Advanced Search and Selection Ltd and has been operating since 2004. We are registered and licensed to recruit through the United Kingdom, mainland Europe and the Americas - we have offices both in the UK and in Switzerland. We are a recruitment business dedicated to the pharmaceutical industry, specialising in Regulatory Affairs.
We match professional candidates to the best permanent, contract and interim roles in the market. For more information about the company visit us at .
We provide a high level of service because we believe this matters. Regulatory professionals will find we know our recruitment subject matter.