The Director, RA CMC Combination Products will work cross-functionally to lead development and implementation of global combination product/Medical Devices regulatory strategies across all applicable programs and lifecycle stages in accordance with program objectives.  This position serves as the Regulatory representative for combination products on applicable Team, Program and Leadership forums.  This position will support interactions with global regulatory authorities, Notified Bodies, and coordinate all aspects of combination product submissions worldwide.

Summary of Key Responsibilities

• Provides leadership and guidance to various stakeholders to ensure development and implementation of innovative global regulatory strategies across Alnylam’s portfolio of combination/device products
• Provides technical, strategic and tactical regulatory guidance to matrixed product development teams
• Defines and optimizes global regulatory strategies pertaining to the development, registration, commercialization and life cycle management of combination/device products
• Proactively identifies, analyses and manages complex combination product and device-related regulatory risks, ensuring timely communication with relevant stakeholders and management
• Inform the strategy and develop content plans for combination product/device-related aspects of global regulatory submissions (e.g., Core Dossiers, INDs, CTAs, BLAs, MAAs, Variations, Technical Files, Notified Body Opinions, etc.)
• Builds and manages relationships through active partnering with key internal and external stakeholders
• Works effectively across a complex matrix environment with GRLs, CMC RA, Program Leadership, CMC functions, etc. to ensure effective strategies are developed and project execution is on kept on target
• Relationship management and constructive partnering with global Health Authorities (e.g., FDA, EMA, PMDA, NMPA, Competent Authorities, etc.)
• Support regulatory interactions on Combination Products related topics
• Identify potential regulatory risks to the strategic/operational plans and propose options to mitigate risks.
• Represent Alnylam RA CMC at external combination product/device related forums/panels

Qualifications

• BS in science related field required. Advanced degree (eg MS, PhD) preferred.
• Regulatory CMC experience in medical device and combination product research, development and/or manufacturing
• Regulatory CMC experience in authoring and review of (IND, CTA, BLA, MAA) with a drug-device combination product
• 10+ years of experience in the pharmaceutical/biotechnology/life science industry, with a minimum of 5+ years demonstrated experience in combination products
• Experience developing strategy for development and/or commercial combination products, managing and preparing submissions
• Solid understanding of scientific principles and regulatory requirements relevant to global drug-device combination product development, registration and post-market support
• Experience interfacing with FDA, EMA and/or other global regulatory agencies
• Knowledge and understanding of US and EU combination product guidance and requirements.
• Ability to develop creative but compliant solutions to keep programs on track
• Strong interpersonal skills and ability to collaborate effectively with various technical area experts and internal or external partners.
• Membership/panelist/presenter within a combination-products related professional society/forum
• 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).