Sr. Manager, Regulatory Affairs, CMC

Sr. Manager, Regulatory Affairs, CMC

Alnylam Pharmaceuticals

Amsterdam or Maidenhead

The Sr Manager, Regulatory Affairs CMC is responsible for supporting and executing department-wide global regulatory compliance and process improvement strategies, with input from key Regulatory, Quality and CMC stakeholders. These strategies ensure Alnylam’s program(s) meet global health authority requirements and remain compliant throughout the lifecycle of the product. This role will support core capabilities and strategic innovation activities of the RA CMC team, allowing for global clinical development, registration, and product life cycle management in a streamlined, efficient, and compliant manner.

Summary of Key Responsibilities

• Ensures that regulatory submissions and CMC projects align with RA CMC best practices and defined regulatory strategy/program objectives. Proactively identifies compliance gaps or process improvement needs and works with the RA CMC team to develop mitigation proposals;
• Contributes to the implementation of process improvement initiatives supporting the RA CMC function;
• Support generation and reporting of metrics for the RA CMC team (i.e change control, submission metrics);
• Contribute to development of best practices and standardized processes;
• Maintain project dashboard(s);
• Manages regulatory compliance activities including periodic regulatory reporting, review of technical documents, and providing regulatory assessments;
• Actively participates in the development of regulatory CMC infrastructure and capability building.

Requirements

• BS in science related field required, advanced degree (eg MS, PhD) preferred;
• Minimum 4-6 years of experience in the pharmaceutical/biotechnology/life science industry, including at least 2 years of RA or CMC experience;
• Experience working on GMP inspections, audits, investigations or other quality systems, Experience in formal risk assessment (i.e. FMEA) a plus;
• Process improvement experience; Lean/Six Sigma certifications a plus;
• Sound understanding of chemistry and biology. Experience in oligonucleotides is a plus;
• Knowledge and understanding of US, EU, Canada, and ICH guidelines as well as understanding of international CMC requirements. Combination products experience a plus;
• Strong interpersonal skills and the ability to effectively collaborate with various technical area experts;
• Excellent verbal and written and communication skills;
• Demonstrated strong organizational skills including ability to review and execute complex project plans;
• Highly computer literate (e.g., Word, Excel, PowerPoint).

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