OPTION SUISSE ** Do you have strong EU and want to gain global? ** Senior CMC RA Manager, global roles, early and late as well as BLA/MAA submissions **

Reference: TM10397

Expiry Date: 07-02-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time


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Job Description


My client is an expanding bio-pharmaceutical company with an impressive line-up of well-known technical experts both in regulatory and within the CMC sub teams you will collaborate with. This will be one of those areas where you can really continue to add depth of your expertise, as you will be given specific projects in late stage to submission straight away, as well as pick up learning about defining overall strategy in early stage development.

My client is a past placement, we have known him for over 12 years, and he combines a strong level of understanding in how to grow your skills, with the global technical RA track record, to help you climb up the ladder.

The company has more than several bio projects in the pipeline, and are a Business Unit bio franchise of a global giant, so the company has superb prospects for you, and does not do things in halves.


As a minimum you will have filed complex variations for DS or DP, or filed a MAA or BLA as part of a bigger team, or working under a Director of CMC GRL. You will have mAb experience, or near equivalent, and have a thorough understand of the EU regulatory framework and now would like to gain more global (including US) submissions experience; you might have more experience in this, and we can offer a more senior role, so if this is also the case, please apply and mention this in your email. IMPD experience would also be useful.

Relocation & Package

My client is willing to fund a relocation to Switzerland, including financial and logistical support for finding a new place to live, registration with the Canton for Residency and Work Permit (this is fairly quick in Switzerland).  The location will allow you to ski in your spare time, and is pretty breath-taking, and the company is based in a brand new site, with great facilities and connections to Lausanne, Nyon and Geneva.

Additionally, the role comes with a bonus, 13th month, and Swiss level salary (approx. 1.6 times Eurozone salaries). 

Advanced Regulatory and our parent company ADV Talent Partners, will assist you every step of the way in your application and from all our staff, we wish you a happy new year and start to 2019!


To apply!

To apply for this role, please register on this web site. Your information is safeguarded for GDPR, and you will have the right to edit, amend or delete your registration.

We would welcome a phone call if you have any questions, or if you would like to find out more about the role, then please contact me, Theo Moore, or my colleague Matt Greig, on +44(0)2078013384 or in the evenings on +44(0)7918679405.


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