Associate Director, Regulatory Affairs

Alnylam Pharmaceuticals; United Kingdom; Hybrid; GBP 60,000 - 100,000; Full time

Job summary

Join a pioneering company at the forefront of RNA interference therapeutics as a Regulatory Affairs Associate Director. In this hybrid role, you will lead the regulatory strategy for the UK and Ireland, ensuring successful submissions and compliance for innovative products. Collaborate with cross-functional teams to navigate the regulatory landscape, support product launches, and maintain strong relationships with regulatory authorities. This is an exciting opportunity to contribute to groundbreaking medicines and be part of a culture that values innovation, diversity, and excellence.

Qualifications

• Experience with regulatory authorities for innovative products.
• Knowledge of UK Regulatory Affairs and Brexit implications.

Responsibilities

• Develop and implement regulatory strategy for UK products.
• Manage submission processes and ensure compliance with regulations.
• Lead interactions with regulatory authorities like MHRA/HPRA.

Skills

Regulatory Affairs

Communication Skills

Analytical Skills

Project Management

Relationship Building

Education

University Degree in Science

Job description

This role is considered Hybrid.

The Regulatory Affairs Associate Director for UK and Ireland has responsibility for the UK regulatory strategy within a development team. Serve as team lead or co-lead of marketing application submissions that are at the regulatory filing stage and life cycle maintenance of registered drugs; helping to develop strategy and content for local dossiers.

Summary of Key Responsibilities:

1. Participates in the development and implementation of regulatory strategy for the UK for products in development and marketed products, as applicable
2. Manages the process for the successful preparation, submission, and timely approval of applications (CTAs, initial marketing applications, supplements, labeling changes, etc.) and general product life cycle maintenance
3. Ensures compliance with regulatory requirements and regulatory files
4. Manages interactions with MHRA/HPRA and attends meetings with HA when required
5. Provides strategic regulatory leadership to the Country General Manager to support successful product launches
6. Works closely with supply chain and quality assurance, including UK Qualified person, to identify UK/IE-specific regulatory requirements and potential risks, and provides support for obtaining GMP / GDP licenses, as relevant
7. Supports/follows-up on submissions to EMA (variation, commitment, etc., impacting Ireland)
8. Leads regulatory review of commercial/medical materials in partnership with internal groups and external Regulatory partners, if necessary
9. Leads regulatory review of artworks in partnership with Supply Chain and RA labeling
10. Leads regulatory review of educational materials if applicable, including submissions and negotiations with MHRA/HPRA
11. Leads negotiations with MHRA/HPRA, as applicable
12. Manages relationships with CROs and Regulatory Affairs consultancies to ensure business objectives are met
13. Contributes to the development of new regulatory guidance and communicates the impact of regulatory changes across the organization
14. Maintains dashboard of country-specific activities, including label management and other regulatory activities
15. Provides input into the implementation of a Regulatory Information Management system (RIM) to track regulatory activities, including label changes, in country-specific databases like emc or medicnes.ie
16. Trains new team members to ensure successful onboarding, as applicable

Requirements

• Sound knowledge and experience working with regulatory authorities, especially regarding submissions for innovative products in late-stage development and post-approval
• Extensive knowledge of UK Regulatory Affairs and related requirements, including Brexit
• University Degree in Science or a related discipline
• Experience interfacing with Regulatory Authorities in Europe and/or MHRA/HPRA and building strong relationships
• Experience in both large companies and smaller, adaptable companies
• Ability to work in a high-visibility, fast-paced environment, with flexibility, attention to detail, and strong analytical skills
• Strong team player with the initiative to work independently and take ownership
• Excellent communication skills to interact with commercial, medical, PV, supply chain, quality, and other regulatory functions
• Results-oriented, capable of working under pressure and meeting deadlines
• Confident with professional credibility to represent the company externally

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has pioneered RNA interference (RNAi) therapeutics, transforming lives with innovative medicines based on Nobel Prize-winning science. Since 2002, Alnylam continues to lead the RNAi Revolution, turning scientific potential into reality.

Our culture: Our people-first culture is guided by core values: innovation, openness, urgency, excellence, and commitment to people. Recognized globally as a top employer, we foster an inclusive environment where employees feel they belong, can be authentic, and achieve their full potential. We are committed to diversity and equal opportunity, enabling groundbreaking medicines for patients.