Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites.
Roche is an equal opportunity employer.
As EEMEA Hub Technical Regulatory Manager you are part of the “Pharma Technical Regulatory” department in Pharma Technical Operations.
Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.
Pharma Technical Regulatory (PTR) provides the strategy, expertise and guidance to ensure world-class technical regulatory support for clinical trial applications, new molecular entity market applications, and post-approval change submissions. PTR’s primary roles are to develop and implement technical regulatory strategies, to deliver Chemistry, Manufacturing and Controls (CMC) dossiers and to provide expertise to technical development and technical product teams. Furthermore, PTR collaborates with health authorities and industry groups and supports the relevant pharma quality systems.
An excellent temporary (3 years) position has been opened in the PTR EEMEA International Operations team for a professional who is a CMC subject matter expert (SME) and/or experienced in managing regulatory activities in multiple countries from preferably Eastern Europe, Middle East and Africa (EEMEA) markets.
In this role you will be responsible for execution and management of regional life-cycle submissions for Roche products (both small molecules and biologic entities) as well as NDA/BLA/MAA by addressing local requirements to ensure right first-time submissions to Health Authorities. Your expertise will be crucial to maximize efficiency and quality of the filings and optimize time to get Health Authority (HA) approval.
You will act as a primary technical (CMC) regulatory point of contact for the Affiliate DRAs from the EEMEA region. You will be an SME in regulatory requirements for CMC submissions by providing country/region specific guidance to Technical Regulatory Teams. In coordination with global Technical Regulatory Leaders, you will develop and execute the regulatory strategy for CMC lifecycle submissions originating at Roche/CMO manufacturing sites or affiliates that include, not exclusively, regulatory change assessment.
In addition you will:
This is a temporary position for 3 years, based in Basel, Switzerland.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
You have a University Degree (advance degree preferred) and overall 3 to 8 years of experience in the pharmaceutical industry. You bring solid demonstrated experience in Regulatory Affairs for CMC requirements for small molecules and/or biologic products, development and/or manufacturing and/or quality assurance for at least some of EEMEA markets. You have an excellent understanding of the regulatory environment and requirements and you are able to develop optimal regulatory strategies.
Don’t hesitate to apply if you:
Please apply until: 7 October 2017.
F. Hoffmann-La Roche AG
T: +41 61 688 60 61
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