This role is considered Hybrid.

Associate Director, Regulatory Compliance

Overview

The Associate Director, Regulatory Compliance will help develop and drive department-wide global regulatory compliance strategies, with input from key program, Regulatory, Quality and CMC stakeholders. These strategies will be designed to ensure Alnylam’s program(s) meet global health authority requirements and remain compliant throughout the lifecycle of the product. This role will oversee core capabilities and strategic innovation activities of the RA CMC team. This role is a critical position to ensure successful global clinical development, registration, and product life cycle management in a streamlined, efficient, and compliant manner.

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.
• 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.

Qualifications

• BS in science related field required. Advanced degree (eg MS, PhD) preferred.
• 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
• 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.
• 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), Experience using Smartsheets, Veeva and Docubridge desirable

About Alnylam

We are the leader in RNAi therapeutics – a revolutionary approach with the potential to transform the lives of people with rare and common diseases. Built on Nobel Prize-winning science, Alnylam has delivered the breakthroughs that made RNAi therapeutics possible and are just at the beginning of what’s possible. Our deep pipeline, late-stage programs, and bold vision reflect our core values: fierce innovation, passion for excellence, purposeful urgency, open culture and commitment to people. We're proud to be a globally recognized top employer, where an authentic, inclusive culture and breakthrough thinking fuel one another.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. Qualified applicants will receive consideration for employment without regard to their sex, gender or gender identity, sexual orientation, race, color, ethnicity, national origin, ancestry, citizenship, religion, creed, physical or mental disability, pregnancy status or related conditions, genetic information, veteran or military status, marital or familial status, political affiliation, age, or any other factor protected by federal, state, or local law. Alnylam is an E-Verify Employer.