Senior Manager, Regulatory Affairs

Job Title: Associate Director, Regulatory Affairs

Job Type: Permanent, full-time position

Location: Berkshire, UK – 3 days on-site per week

Remuneration: Attractive salary and package

We are partnered with a leading Pharmaceutical organisation who are looking for an experienced Associate Director, Regulatory Affairs to join their Neuroscience division. This role will be leading 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 complex EU CP submissions. The ideal profile will have experience with complex therapeutic areas.

Responsibilities:

1. 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.
2. Support interactions with the EMA at both early and late stages of drug development including national agencies.
3. Confident with both pre and post-approval activities including initial MAA, variations, and renewals.
4. Support clinical trials under EU CTR, scientific advice, and PIPs.
5. Provide strategic input for registration, ensure 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.
6. Receive delegation to manage EMA meetings and other agency key meetings in liaison with affiliate regulatory managers.
7. Responsible for planning and ultimately leading MAA-related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
8. Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).

Qualifications:

1. To be considered for this role, you should be a graduate in pharmacy, biology, chemistry, pharmacology, or related life sciences subject.
2. 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).
3. At least 8/10 years of experience in a Regulatory Affairs role within the pharma/Biotech/CRO industry.
4. Ideally a background in Neuroscience or other complex therapy areas.
5. Experience of managing and developing staff members desirable but NOT a must.
6. Experience in dealings with the EMA (scientific advice, orphan designation, PIPs).
7. Experience of providing EU regulatory strategy.
8. Experience of bringing a product through EU approval is a distinct advantage.
9. 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.

If you are interested in this role or would like more details please email your CV to lucy.kirkaldy@cpl.com