Regulatory Affairs Senior Manager

One of our major clients, is looking for a Regulatory Affairs Senior Manager, able to provide regulatory support and guidance to supply & planning, quality, manufacturing, logistics functions as needed.

Responsibilities:

• Responsible for defining Biosimilar regulatory strategies for assigned projects and programs and for obtaining project team alignment on those strategies
• Regulatory representative with strategic partner(s) for assigned projects and programmers and responsible for securing partner alignment on regulatory strategy
• Responsible for implementing defined regulatory strategies, including filing of all appropriate regulatory submissions for assigned projects and programs
• Responsible for leading the co-ordination of all aspects of regulatory submissions relevant to assigned projects or programs
• Responsible for the development of core aRMMs and for leading their customisation, submission, approval and dissemination across markets. Responsible for the implementation of updates to approved aRMMs
• Define Biosimilar labelling strategy, taking into account commercial and medical drivers.

Must Haves:

• 6-years’ experience in the pharmaceutical/biotechnology industry with at least 4-years’ experience in regulatory affairs
• Experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
• Good knowledge of applicable regulations, regulatory guidelines and submission requirements and ability to interpret regulations and guidelines

Country: Switzerland

Schedule: Full time

Desired start date: ASAP

Duration: 1 year contract

Please note that we can only accept applications from EU/CH citizens.

If this sounds like you please reach out to me at jtoma@actalentservices.com

Job Title: Regulatory Affairs Senior Manager

Location: Basel, Switzerland

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield