Alnylam Pharmaceuticals · 4 months ago
Associate Director, Regulatory Compliance
Cambridge, MA
Full-time
Onsite
Lead/Staff, Director/Executive
$164K/yr - $222K/yr
8+ years expAlnylam Pharmaceuticals is a leader in RNAi therapeutics, and they are seeking an Associate Director of Regulatory Compliance. This role involves developing global regulatory compliance strategies to ensure product lifecycle management and compliance with health authority requirements.
BiotechnologyHealth CareMedicalPharmaceuticalTherapeutics
Responsibilities
Leads and manages Compliance activities on behalf of the RA CMC organization and serve as the point of contact for Regulatory CMC on audits & inspections
Support development and management of a program for tracking, execution, monitoring, and reporting on RA CMC processes (Metrics and KPIs) to drive excellence in Regulatory CMC pre- and post-submission activities
Leverages strong scientific understanding of biochemistry and pharmaceutical development to develop sound regulatory strategies for novel molecules, processes or formulations
Utilizes technical knowledge, regulatory expertise and global regulatory lessons learned to shape global regulatory best practices, drive internal consistency and influence effective change management
Collaborates across RA CMC to ensure clear and timely communication about compliance risks, business processes, compliance activities and metrics arising on programs
Work cross-functionally with Regulatory, Quality, and CMC to support global strategic initiatives related to pre and post submission activities and the processes and systems used to manage compliance
Serve as RA CMC point of contact for Compliance and QMS operational activities
Maintain knowledge of the global regulatory environment, regulations, and guidelines and participate in regulatory intelligence activities to help ensure Alnylam dossiers remain in compliance with shifting expectations
Escalate issues/problems to RA CMC LT as needed and propose risk-based remediation actions for consideration
Working with other RA CMC functions, ensure RA CMC Commitments (i.e. IND, post marketing) and Quality Events are managed within specified timelines
Identify opportunities to improve RA CMC compliance capabilities through digital solutions and automation
Actively participate in RA CMC process improvement and capability building
Qualification
Required
BS in science related field required
8+ years of experience in the pharmaceutical/biotechnology/life science industry, with direct hands-on experience in relevant fields, such as Product Quality, Quality Systems, CMC Technical Writing or Regulatory Affairs, CMC
Nuanced understanding of regulatory risk and ability to develop risk mitigation strategies
Experience in technical systems and mining data for trends, resulting in meaningful and reportable metrics
Experience managing and/or preparing submissions, with the ability to optimize/streamline processes
Solid understanding of scientific principles and regulatory requirements relevant to global product development, registration and post-market support
Strong interpersonal skills; ability to influence key stakeholders
Excellent written and communication skills and attention to detail
Demonstrated strong organizational skills including ability to prioritize tasks and adhere to agreed timelines
Highly computer literate (eg, Word, Excel, PowerPoint)
Preferred
Advanced degree (eg MS, PhD) preferred
Membership and active participation, including Presenter or Committee membership in Industry Organizations (DIA, BIO, RAPs, etc.)
Experience in managing complex CMC changes (eg process, facility, formulation)
Knowledge and understanding of US, EU, Canada, and ICH guidelines pertinent to CMC. Understanding of international requirements is a plus
Experience using Smartsheets, Veeva and Docubridge desirable
Benefits
Comprehensive benefits including medical, dental, and vision coverage
Life and disability insurance
A lifestyle reimbursement program
Flexible spending and health savings accounts
401(k) with a generous company match
Paid time off
Wellness days
Holidays
Two company-wide recharge breaks
Generous family resources and leave
Company
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is a biopharmaceutical company focused on the discovery, development and commercialization.
1001-5000 employees
H1B Sponsorship
Alnylam Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (18)
2021 (19)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
$4.55BKey Investors
Blackstone Life SciencesBlackstone CreditRegeneron
2025-09-09Post Ipo Debt· $661.25M
2022-09-12Post Ipo Debt· $900M
2022-03-04IPO
Leadership Team
Yvonne Greenstreet
Chief Executive Officer
Jeff Poulton
Chief Financial Officer
Recent News
Clinical Trials Arena
2026-01-16
Longevity.Technology
2026-01-14
2026-01-13
Company data provided by crunchbase