Associate Manager I – Reg CMC Strategy

Pfizer, S.A. de C.V; Chennai District; On-site; INR 1,000,000 - 1,800,000; Full time

Job summary

Pfizer is seeking a Regulatory Affairs professional with 3–7 years of CMC regulatory experience to lead strategic execution for post-approval changes, and to coordinate global submissions across modules. The role involves drafting regulatory strategies, responding to HA queries, and liaising with cross-functional teams to ensure timely delivery.

The candidate should have postgraduate credentials in Pharmacy or Science, strong communication, and the ability to work in a matrixed environment while

Qualifications

• Postgraduate in Pharmacy or Science.
• 3 to 7 years of CMC experience within regulatory function with knowledge of EU/US and international practices.
• Proficiency in Trackwise, GDMS, PDM, SPA and related tools.
• Good verbal and written communication skills.
• Ability to work in a matrixed environment and meet timelines.

Responsibilities

• Functions as CMC author/strategist for development and execution of regulatory strategies for assigned changes including minor and/or moderate post-approval changes.
• Responsible for end-to-end PCF assessment.
• Authors and compiles responses to HA queries within agency timelines.
• Mentor-led development for complex CMC changes when identified.
• Reviews proposed changes for completeness and develops global regulatory strategy.

Skills

Regulatory knowledge

Communication skills

Team collaboration

Time management

Attention to detail

Education

Postgraduate in Pharmacy or Science

Tools

Trackwise

GDMS

PDM

SPA

Job description

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life-changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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.

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