Associate Ii
2 months ago
Functions as Regulatory support for CMC Devices team to support the device programs and life-cycle management (LCM) regulatory activities. The responsibilities as an individual contributor include but not limited to supporting the
- 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.
- Support of assurance of 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.
- Authors key pieces of regulatory strategy and/ or submissions as delegated by the Product/Project Lead(s) (additional to assigned products), on need.
- Supports 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.
- 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 line leadership.
- Suggests, supports and implements system improvements to ensure regulatory compliance, to reduce cycle time and to create efficiency.
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.
Qualifications:
- Preferred Education:
Bachelors or Master (Biotechnology/ Pharmacy/ Science) or Ph. D (Biotechnology/Biological Sciences)
- Preferred Experience:
Minimum 0-2 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. Subject/ working knowledge of EU MDR, 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 understanding of 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.
- Basic knowledge and understanding of Design History Files (DHF) and other documents related to design verification (DVer).
- Familiarity of 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
- Basic 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.
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
LI-PFE
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