Associate II, Reg CMC Strategy

Pfizer; Chennai; Hybrid; INR 900,000 - 1,300,000; Full time

Job summary

Pfizer in Chennai is seeking an Associate II, Reg CMC Strategy to lead development of CMC regulatory strategies, submissions and compliance for commercial products. The role works within a hybrid team and interfaces with global regulatory partners to align on strategy and timelines.

You will drive post-approval changes, assess regulatory risks, prepare submission materials, and represent CMC in cross-functional teams, resolving issues with guidance from the Team Lead.

Responsibilities

• Provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects.
• Prepare the CMC information for submission to global regulatory agencies and develop mitigation plans.
• Act as the global CMC representative within cross-functional project teams and interpret regulations for global implications.
• Manage daily delivery of regulatory and strategic activities including post-approval changes and compliance.
• Resolve issues and manage regulatory risks within project teams and escalate complex issues as needed.
• Ensure compliance with Pfizer policies and participate in cross-disciplinary forums and learning opportunities.

Job description

Associate II, Reg CMC Strategy### Associate II, Reg CMC StrategyBewerben: India - Chennai: Vollzeit: Heute ausgeschrieben: 4966490**Functions as a CMC strategist for the development of CMC regulatory strategies, submissions and compliance activities for commercial pharmaceutical products supporting HBU’s Business. Work is periodically reviewed by Team Lead.** **Provides and drives strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering post approval activities. Prepares the CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans.** **Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions.** **Primary accountable for assigned CMC products, managing daily delivery of regulatory and strategic activities, including post-approval changes and compliance activities.** **May represent CMC during interactions with internal partners either directly or in conjunction with Team Lead.** **Resolve issues and manage regulatory risks within project teams.** **Makes decisions to resolve moderate problems in standard situations as per the guidance and policies and escalates complex issues / risks to appropriate leadership.** **Ensure compliance to Pfizer's training activities (e.g. functional, compliance-related, HR policies) & individual development plans, participate in cross-disciplinary forums & learning opportunities, demonstrating & modeling adherence to all Pfizer behaviors & values, embracing & complying with Principles of Integrity.** **Utilize Pfizer’s CMC systems, i.e. GDMS, PDM, SPA, Rosetta, etc, as appropriate.** Work Location Assignment: Hybrid 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