Associate Manager I – Reg CMC Strategy

Biopharma Careers; Chennai District; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Pfizer is seeking a CMC regulatory affairs professional to execute regulatory strategies for post-approval changes globally in coordination with GRS-CMC. You will manage day-to-day regulatory activities for assigned PCFs, liaise with cross-functional teams, and ensure timely deliverables in a structured environment under supervision.

Responsibilities include authoring regulatory strategy documents, responding to HA queries, and coordinating submission packages (Module 1, 2.3, M3.2S/P/R) as

Qualifications

• Postgraduate in Pharmacy or Science required.
• 3–7 years CMC regulatory experience; EU/US knowledge.
• Proficient in Trackwise, GDMS, PDM; strong document management.

Responsibilities

• Act as CMC author/strategist for regulatory strategies for changes.
• End-to-end PCF assessment.
• Draft responses to HA queries within timelines.
• Mentored projects for complex CMC changes.
• Review changes and develop global regulatory strategy.

Skills

CMC experience

Regulatory knowledge

Document systems

Education

Postgraduate in Pharmacy or Science

Tools

Trackwise

GDMS

PDM

Job description

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.
• Mantains 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs