Regulatory Affairs Manager
3 weeks ago
Job Type: Permanent, full-time position
Location: Berkshire, UK – 3 days on-site per week
Remuneration: £70,000 - £80,000 + benefits
We are seeking an experienced Senior Regulatory Affairs Manager to join our Neuroscience division. This role will be leading European strategy for a developing and marketed Neurology portfolio.
As a Senior Manager, Regulatory Affairs, you will have excellent experience with both developing and marketed products and be confident with complex EU CP submissions. The ideal profile will have experience with complex therapeutic areas.
Responsibilities:
• 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, in alignment with the overarching global regulatory strategy and region-specific requirements.
• Supporting interactions with the EMA at both early and late stages of drug development, including national agencies.
• Confident with both pre and post-approval activities, including initial MAA, variations, and renewals.
• Support clinical trials under EU CTR, scientific advice, and PIPS.
• Provide strategic input for registration, ensuring the business needs are met by anticipating and mitigating regulatory risks while ensuring compliance with regulations, assess probability of success for submission, approval, and launch.
• Receives delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers.
• Responsible for planning and ultimately leading MAA-related processes and strategy to ensure timely product approvals with competitively differentiated labeling.
• Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
Qualifications:
• To be considered for this role, you should be a graduate in pharmacy, biology, chemistry, pharmacology, or related life sciences subject.
• You should also have sound knowledge of both pharmaceutical regulations and guidelines and national regulations within the assigned region, as well as extensive demonstrated prior relevant experience in pharmaceutical Regulatory Affairs and regulatory procedures (including CP/DCP/MRP).
• At least 5/10 years of experience in a Regulatory Affairs role within the pharma/Biotech/CRO industry.
• Ideally a background in Neuroscience or other complex therapy areas.
• Experience of managing and developing staff members desirable but not a must.
• Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
• Experience of providing EU regulatory strategy.
• Experience of bringing a product through EU approval is a distinct advantage.
• Excellent written and verbal communication skills.
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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