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Overview
The Senior Associate of Regulatory Affairs will report to the Director of Global Regulatory Affairs, Strategy, located in Maidenhead, UK. The role will provide cross-program support to prepare and facilitate submission of regulatory packages to various international health authorities (HAs) to support product development, clinical trials, product registration, and post-approval lifecycle management.
This role is considered Hybrid, with an office-based requirement of 2 days per week in Maidenhead, UK.
Key Responsibilities
* Support regulatory strategy by working with Regional Leads and cross-functional teams, ensuring timely submission of regulatory documents such as CTAs, INDs, amendments, periodic reports (e.g., DSUR, PBRER), and variations.
* Coordinate responses to regulatory authority questions, adhering to deadlines.
* Manage all aspects of regulatory submissions, both paper and electronic, maintaining regulatory files per SOPs.
* Develop and track detailed regulatory project plans and timelines, supporting activities for assigned products/projects.
* Assist in writing and reviewing regulatory documents, facilitating coordinated reviews, and implementing document changes as needed.
* Participate as a member of Global Regulatory Teams and represent regulatory interests in multidisciplinary sub-teams.
* Act as a liaison within internal departments, CROs, and regulatory program managers at HAs.
* Stay updated on relevant regulatory requirements and share intelligence with internal teams.
Qualifications
* Bachelor's degree in a scientific discipline, with 1-2 years’ experience in Regulatory Affairs in biotech/pharma, or PhD without industry experience.
* Understanding of regulations and guidelines interpretation.
* Excellent communication, negotiation, and influencing skills.
* Strong organizational and project management abilities.
* Critical thinking skills.
* Ability to work effectively in a matrix environment and collaborate with various departments and external partners.
* Strategic thinking and proactive issue mitigation skills.
About Alnylam
Alnylam Pharmaceuticals (Nasdaq: ALNY) pioneers RNA interference (RNAi) therapeutics, transforming lives through innovative medicines. Founded in 2002, Alnylam leads the RNAi revolution, translating Nobel-winning science into real-world treatments.
Our Culture
We foster a people-first culture rooted in innovation, openness, urgency, excellence, and inclusivity. Recognized globally as a top employer, we are committed to diversity, equity, and inclusion, empowering employees to bring their authentic selves to work and achieve their full potential.
Additional Information
Position: Mid-Senior level, Full-time, in the Legal job function.
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