Senior Manager, Regulatory Affairs in Maidenhead - Alnylam Pharmaceuticals

Job Overview

Location
Maidenhead, England
Job Type
Full Time
Salary
TBC
Date Posted
12 days ago

Additional Details

Job ID
43009441
Job Views
1

Job Description

Work_Category - hybridDescription

Alnylam (Nasdaq: ALNY) is delivering on a bold vision to turn scientific possibility into reality, with a robust RNA interference (RNAi) therapeutics platform. As the pioneer in RNAi and the leading RNAi therapeutics company, we have always been uncompromisingly dedicated to translating the breakthrough science into transformational medicines to help as many people as possible. Long focused on rare and genetic diseases, our scientific advances are now allowing us to bring the power of RNAi therapeutics to more prevalent diseases and as a result, we are beginning to recognize the full potential of this new class of medicines.

Alnylam is committed to its journey to become a top 5 independent, global biopharma company. We are already admired and recognized for our dedication to patients, company culture that empowers people to do their best work, track record of scientific innovation, social responsibility, and commercial excellence.

Founded in 2002, and headquartered in Cambridge, Mass., Alnylam has over 1,650 employees at work across the globe. We are seeking smart, passionate, “change the world” kind of people who are ready to say, “challenge accepted” to our mission. Thanks to the commitment of every employee globally, Alnylam is proud to have been recognized as one of Fast Company’s 2021 Best Workplaces for Innovators, a Science Magazine Top Employer three years in a row (2019-2021), a Boston Globe Top Places to Work seven years in a row (2015-2021), a Great Place to Work in Asia, Japan, Brazil, the U.K., Germany, Spain, Netherlands, Italy, France and Switzerland, Seramount’s 100 Best Companies (formerly Working Mother 100 Best Companies) and Best Companies for Dads, Bloomberg’s Gender Equality Index two years in a row (2021-2022), among others.  At Alnylam, we are committed to fostering a diverse, equitable and inclusive work environment, culture, and workforce, and we support several Employee Resource Networks.

Summary of Key Responsibilities

Serve as EU Regional Lead for assigned program, or as Regulatory Program Lead, leading the Global Regulatory Team, for one of the early programs in the Alnylam pipeline.Work with the Global Regulatory Lead and Regulatory Affairs management to lead and define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements and lead EU HA interactions. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for HA meetings, new Clinical Trial Applications (CTAs), Marketing Applications, Pediatric Plans, Orphan Designation and Expedited Pathway Applications, and any amendments.Develop detailed regulatory project plans and support regulatory activities relating to specific portfolio of products/projects.Serve as member of the Global Regulatory Team, may serve as Regulatory representative in multidisciplinary product subteams or core team for assigned programs and participate as an active team member.Provide strategic regulatory advice to project teams.Coordinate responses to regulatory authorities’ questions with strict adherence to deadlines.Serve as a liaison within internal departments at Alnylam, with CROs and with regulatory program managers at HAs.Maintain regulatory files in a format consistent with internal requirements.Facilitate as necessary the review of technical regulatory documentation and recommend changes to documentation or processes, including SOPs for regulatory compliance.

Qualifications

Bachelor's degree with proven experience in a Regulatory Affairs role in the biotech or pharmaceutical industry.Excellent written and verbal communication skills, including negotiation and influencing skills.Solid understanding of regulations and experience in interpretation of guidelines.Ability to think strategically and to proactively identify issues and mitigation strategies in various aspects of the drug development process.Experience with regulatory filings, including electronic submissions, e.g., CTAs, INDs, HA briefing documents, Paediatric Investigation Plans etc.Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects.Ability to work in a team environment, possessing interpersonal skills to work effectively with other departments at various levels and with CROs and external consultants.Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.Clear alignment with Alnylam Core Values including:
Commitment to People,Innovation and Discovery,Sense of Urgency,Open CulturePassion for Excellence.

Alnylam Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment.

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