Associate Manager I – Reg CMC Strategy
- India - Chennai
- India - Pfizer Centre
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.
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
Breakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Pfizer Research & Development
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.
With an unwavering commitment to innovation, we use a multidisciplinary approach that blends scientific expertise, cutting-edge technologies, and strategic collaborations, igniting a powerful engine that propels groundbreaking discoveries into life-saving treatments for patients in need.
Through our relentless pursuit of progress, we envision a future where cutting-edge medicines pave the way to healthier, happier lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)