Regulatory Affairs Director
3 weeks ago
Job Summary:
We are seeking an experienced Associate Director, Regulatory Affairs to join our Neuroscience division. The successful candidate will lead European strategy for a developing and marketed Neurology portfolio.
Key Responsibilities:
- Develop and implement regulatory strategies for early/late development and marketed products in Neuroscience for Europe and non-EU CEE countries, Israel, Turkey, Switzerland, and the UK.
- Support interactions with the EMA at both early and late stages of drug development, including national agencies.
- Manage pre and post-approval activities, including initial MAA, variations, and renewals.
- Provide strategic input for registration, ensuring the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations.
- Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance.
Requirements:
- Graduate in pharmacy, biology, chemistry, pharmacology, or related life sciences subject.
- Sound knowledge of pharmaceutical regulations and guidelines, as well as national regulations within the assigned region.
- At least 8/10 years of experience in a Regulatory Affairs role within the pharma/Biotech/CRO industry.
- Ideal background in Neuroscience or other complex therapy areas.
- Experience in managing and developing staff members desirable but not a must.
- Excellent written and verbal communication skills.
What We Offer:
This is a great opportunity for a science-minded individual to work at the heart of innovation on a developing Neuroscience portfolio. You will take the lead and work with senior board members across the globe to define regulatory/business strategy.
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Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This role will lead European strategy for a developing and marketed Neurology portfolio. As an Associate Director, Regulatory Affairs, you will have excellent experience with both developing and marketed products and be confident with...
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Windsor, Windsor and Maidenhead, United Kingdom Cpl Life Sciences Full timeCpl Life Sciences is seeking an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This role will lead European strategy for a developing and marketed Neurology portfolio. As an Associate Director, Regulatory Affairs, you will have excellent experience with both developing and marketed products and be confident with...
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