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Technical Regulatory Support Manager -5446
Our client is a pioneer in Drug Discovery and Development and one of the frontrunners in Personalised Healthcare. As the world`s largest R&D spender in the pharmaceutical and diagnostics domain, they work in a vast number of drug discovery & therapeutic areas and are highly recognized internationally.
We are currently looking for a Technical Regulatory Support Manager for 12-month contract to be based in Basel, Switzerland.
The perfect candidate has a degree within life sciences or regulatory affairs and has collected first hands-on experience in technical regulatory affairs, with profound knowledge on national and international regulations. Storing project management skills as well as an affinity for IT tools are key to this role.
- Proactively support the technical regulatory department on the execution of submission-related and administrative activities for global technical registrations
- Effectively manage regulatory changes throughout the product life cycle
- Be responsible for preparation and maintenance of CMC documentation in internal document management systems as well as support associate activities Represent PTR on other cross-functional teams, advise cross-functional teams concerning regulatory requirements and work with diverse partners and personalities
- Ensure regulatory compliance together with local and global technical functions as well as assess technical change records for regulatory impact
- Contribute to excellence by finding opportunities, mitigating risks and supporting continuous improvement
- Contribute to driving efficiency by assertively simplifying, trying new ways and cutting out waste
- Performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of the company as well as internal audits and inspections
- Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance
- Monitors and improves tracking/control systems
- Keeps abreast of regulatory procedures and changes
- Direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
Qualifications and Experience:
- Relevant Swiss working/residency permit or Swiss/EU-Citizenship required;
- Must have a Bachelor’s degree – preferably in a scientific field; an advanced degree is a plus
- First hands on experiences ideally in technical regulatory affairs, with profound knowledge on national and international regulations and biotechnology
- Ability to manage projects and have excellent communication skills in English, German is a plus
- Ability to work with IT systems and have a high sense of responsibility concerning CMC data management
- Ability to work in interdisciplinary teams, global project teams and with several interfaces