Founded in 1849, Pfizer is the worlds premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.
Post : Regulatory Affairs, Medical Devices
The purpose of this role is to lead regulatory device strategists to asses/assist Global Regulatory Leads (GRLs) to define the global submission strategy for the Devices CMC team within GRA-India Strategy. He/she needs to provide strategic guidance to assigned projects through a team of regulatory strategists responsible for authoring regulatory submissions and supporting maintenance/compliance activities for devices and combination products; modelling strong mentorship and project management techniques to the Devices CMC team assuring a global focus of goals, strategies and plans. As a lead he/she is directly accountable for ensuring regulatory deliverables of the assigned products in accordance with time, cost and quality expectations for all projects in portfolio through collaborative working relationships with global CMC leads, GRLs and other stake holders (PGS, BTxPS, PTxPS, and external partners). The colleague is responsible for mentoring junior colleagues as and when required and contribute to overall management, alignment and process improvement and drive the appropriate culture and behaviors through the organization in accordance to the Pfizer values.
The major duties and responsibilities are as below
Functions as senior member for the Devices programs and life-cycle management (LCM) regulatory responsibilities for Devices CMC team, GRA-India Strategy Group. 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.
• Contribute to GCMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
• Mentors team(s) 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.
• Responsible 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.
• Responsible for mentoring and coaching the team; being resourceful to the team on functional and behavioral areas and ensures that learning is embedded in the organization. Provide support for new colleague onboarding as a senior member.
• Works with other regulatory staff to ensure application of consistent processes and policies across GRA PHIPL. Directly responsible for ensuring implementation of these processes and policies.
Bachelors or Master (Biotechnology/ Pharmacy/ Science/Engineering) or Ph. D (Biotechnology/Biological Sciences/Engineering)
Minimum 8 – 10 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, ISO13485, 21 CFR 820 and ISO14971 guidelines are highly preferred.
Technical Skills :
• Strong 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.
• Thorough understanding of combination product fill-finish, aseptic processing, and cGMP requirements is highly desirable
• Knowledge on ICH Quality Guidance for development of drugs/biologics/vaccines (Q, S, E and M)
• Ability to review and understand FMEA (uFMEA, dFMEA and pFMEA) required for building risk management sections of the dossier (3.2.R and 2.3.R sections)
• Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
• Knowledge of the CMC business as it relates to drug development, and partnering organizations and systems is desired.
• Experience with CMC regulatory submissions, process development and/or GMP manufacture of clinical and/or commercial products.
• Strong understanding of CMC change management processes and CMC CTD content/structure.
• Understanding of identifying and mitigating compliance risks through proper management of CMC product content
• Ability to comprehend and summarize complex technical data.
• Possesses CMC regulatory knowledge and quality expertise to prepare regulatory assessments, develop & contribute to global regulatory strategies with assistance from management for projects across all aspects of drug development or manufacturing lifecycle.
• Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations.
• Adequate level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry
• Demonstrated commitment & dedication to scientific & regulatory integrity & quality compliance.
Experience : 8 – 10 Years
Qualification : M.Pharm, B.Pharm, M.Sc or Ph.D
Location : Chennai, Tamil Nadu
Industry Type : Pharma / Healthcare/ Clinical research
End Date : 10th January, 2023
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