Job Description

Functions at an individual contributor level within the Devices CMC team of GRA-India Strategy to support the Devices programs and life-cycle management (LCM) regulatory activities. The responsibilities include but not limited to, Maintenance of the expansive combination of CMC product information, market registration details, component level dossier content and compliance of an integrated regulatory change management process to provide a comprehensive and compliant view of the CMC registered details of all products in all markets, in support of Global Devices Team . Assuring product compliance through timely and accurate maintenance of CMC submission documentation and product knowledge in Regulatory systems in collaboration with Global Devices. Manages the preparation and maintenance of core dossiers for original applications and subsequent changes (moderate technical & regulatory complexity); coordinates Query Responses to deficiency letters from Health Authorities, with the assistance of local and regional regulatory colleagues. Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately. Authors key pieces of regulatory strategy and/ or submissions as delegated by the Product/Project Lead(s) (additional to assigned products), on need basis Occasionally mentors team of regulatory strategists responsible for device related submissions; coordinates and presents regulatory data needs and negotiates with and/or influences management, cross functional teams and external partners to ensure regulatory data requirement and the deliverables are met. Serving as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria. Manage regulatory issues, maintain submission information in relevant GCMC systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision. Exhibits business acumen and ensures thorough and timely assessment of change controls in regulatory perspective for the Product Change Forms (PCFs) assigned to the team; influences and provides right direction/ regulatory solutions to various stakeholders on change control matters including complex changes and for changes where the regulations are ambiguous. Provides adequate review support and guidance to the team during strategy development and for authoring regulatory submissions/compliance activities to ensure effective data presentation and quality. Remains knowledgeable and maintains awareness about current regulations and guidance related to Devices and combination products, interprets, assesses impact on development & LCM programs and communicates to necessary functions and leadership. Responsibe for ensuring all regulatory activities for assigned products are executed effectively and efficiently in compliance with external regulatory requirements and internal submission standards, quality procedures and policies framed by Global Regulatory Affairs. QUALIFICATIONS / SKILLS / EXPERIENCE Preferred Education: Bachelors or Master (Biotechnology/ Pharmacy/ Science/Engineering) or Ph. D (Biotechnology/Biological Sciences/Engineering) Preferred Experience: Minimum 4-7 Years of experience in Pharmaceutical/Medical Devices Industry (specializing in combination products) with major experience in Regulatory Affairs group handling new submissions and / or LCM submission (Master file updates, renewal dossier, complaints handling etc) to global health authorities especially USFDA, EMA and other EU authorities. Has an understanding on global strategy and legislation that pertains to combination products in sterile injectable, biologics, vaccines portfolio. Working knowledge of EU MDR (Art 117) , ISO13485, 21 CFR 820 and ISO14971 guidelines are highly preferred. Preferred Attributes: Good oral and written English communication skills. Good conceptual, analytical, problem solving, and organizational skills. An assertive, take-charge, proven manager with a strong result orientation, positive can do attitude, and a sense of urgency to get things done. Can makes decisions to resolve moderately complex problems in standard situations. Makes decisions within guidelines, policies & procedures. Can work independently in ambiguous situations as part of a work team. Technical Skills Good knowledge on the Regulatory requirements for development & LCM of combination products (drug-device) for US, EU and other major markets and has expertise to oversee preparation and submission of complex regulatory dossiers such as IMPD, BLA etc. Strong working knowledge and understanding of Design History Files (DHF) and other documents related to design verification (DVer). Ability to understand the working/primary mode of action of a combination product such as prefilled syringes, cartridges, auto injectors, pen injectors, safety devices and IV bags to liase with development and manufacturing teams. Knowledge on ICH Quality Guidance for development of drugs/biologics/vaccines (Q, S, E and M) Ability to be savvy in handling eCTD tools for authoring and publishing Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management. Strong understanding of CMC change management processes and CMC CTD content/structure. Adequate level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.

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