Pfizer Hiring Reg CMC Strategy Associate Manager

Pfizer is the world's 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 : Associate Manager I – Reg CMC Strategy

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 strategies including response to HA queries.
• Manages day-to-day regulatory activities associated with assigned PCFs within agreed upon time lines.
• Collaborates with Cross Functional Teams (RRHS/PCO/RCM/Site CNM) and GRS-CMC to ensure the deliverables.
• 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 oft he CMC GRS.

• 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 career development, 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.

Candidate Profile
• 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.

Additional Information
Experience : 3 to 7 years
Qualification : Postgraduate in Pharmacy or Science
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Reg CMC Strategy
End Date : 10th October 2026