JOB SUMMARY
Execution of CMC strategies for Pfizer Global Supply (PGS) initiated prioritized post approval changesglobally in collaboration with the CMC GRS. Responsible for development and execution of regulatory strategiesincluding response to HA queries. Manages day-to-day regulatory activities associated with assigned PCFs within agreed upontimelines. Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure thedeliverables. Works in a structured environment with supervision from Team Lead. Liaise with Pfizer Global Supply and other support functions as needed. Use of regulatory systems and management of CMC documentation and information in support ofthe CMC GRS.
JOB RESPONSIBILITIES
Functions as CMC author/strategist for development and execution of regulatory strategies for theassigned changes which include minor and/or moderate post approval changes/projects/products Responsible for end to end PCF assessment Authors and compiles response to HA queries within agency timelines Projects involving complex CMC changes shall be assigned through mentoring as a part of careerdevelopment, if identified Reviews proposed changes for completeness and accuracy and development of initial globalregulatory strategy while considering registered content and seeks endorsement by the CMC GRS. Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMCsubmission packages globally, i.e.Module 1, Module 2.3, M3.2S/P/R under guidance from the CMCGRS as appropriate and within 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
Escalates delays in timelines and contributes to the Identifion and mitigation of risks with the support of TL/designee; flags identified risks to the CMC GRS and/or appropriate leadership Makes decisions to resolve minor problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership Flags identified risks to the CMC GRS and/or appropriate leadership Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges. Coordinates internal document review and sign off. Utilizes Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, etc, as appropriate. Supports Query and/or commitment management in collaboration with CMC GRS. Maintains conformance systems maintenance in support of the CMC GRS.
QUALIFICATIONS / SKILLS
Minimum - Postgraduate in Pharmacy or Science Minimum 3 to 7 years of CMC experience within a regulatory function with 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. Willingness to work flexible hours.
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Regulatory Affairs