Job Description

Minimum - Postgraduate in Pharmacy or Science (Graduates can be considered based on exceptional merit). Minimum6 - 10 years of CMC experience within a regulatory function. Knowledge of EU/US and international regulatory practices, policies. Proficiency in Microsoft windows, Trackwise, Navigation or similar submission management tools document management systems, publishing tools and operating knowledge of databases. Good verbal and written communication skills. Motivated, good interpersonal skills, organized, hardworking, agile, adaptable to change and able to meet timelines. Team player and ability to work in a highly matrixed environment. Customer focus and attention to detail and accuracy is required. Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills. General Development andexecution of CMC strategies forpost approval changes globally in collaboration with global and regional counterparts. Liaise with cross functional teams and other support functions as needed. Use of regulatory systems and management of CMC documentation and information. Specific Manages day-to-day regulatory activities associated with projects assigned. Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content in partnership with global and regional counterparts. Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages(Supplements /Variations)globally, i.e.Module 1, Module 2.3, M3.2S/P/Rwithin agreed timelines. Major and Emerging Market focused. Reviews technical/supportive information for submission to support change. Reviews and applies pertinent global regulatory guidelines. Develops technical justification of change for agency submission. Updates M3 dossier. Coordinates M3.2.R Ancillary documents. Flags identified risks to appropriate leadership. Represents RA CMC point of view and meets with key stakeholders to resolve challenges. Coordinates internal document review and sign off. Utilizes Pfizer\'s CMC regulatory systems, as appropriate. Supports Query and/or commitment management in collaboration with global counterparts. Maintains conformance systems maintenance in support of global counterparts. Work Location Assignment:On Premise 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

foundit