Director, Regulatory Affairs, Cmc - Combination Products Lazio

Director, Regulatory Affairs, Cmc - Combination Products
Roma
Lazio, Lazio

Job Description - Director, Regulatory Affairs, CMC - Combination Products (220858) Overview: 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 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). About Alnylam: Alnylam Pharmaceuticals (Nasdaq : ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality. Our people-first culture is guided by our core values : fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law. Alnylam is an E-Verify employer. J-18808-Ljbffr