Associate II, Reg CMC Strategy

Pfizer; India; Hybrid; INR 1,500,000 - 3,500,000; Full time

Job summary

Pfizer in India seeks a CMC regulatory strategist to lead development of CMC regulatory strategies, submissions and compliance for commercial products. The role involves global coordination, risk assessment and post-approval activities within cross-functional teams.

The position requires driving CMC documentation for regulatory submissions, representing CMC in internal partnerships, and ensuring adherence to Pfizer training and compliance policies in a hybrid work setting.

Responsibilities

• Functions as a CMC strategist for regulatory strategies, submissions and compliance for commercial products.
• Work is periodically reviewed by Team Lead.
• Drives strategic and operational global CMC regulatory direction and documentation for post-approval activities.
• Prepares CMC information for submissions to global regulators; develops contingency plans.
• Acts as global CMC representative within cross-functional teams, interpreting regulations and global implications.
• Primarily accountable for assigned CMC products; manages post-approval changes and compliance.
• May represent CMC in interactions with internal partners with Team Lead.
• Resolves issues and manages regulatory risks within project teams.
• Makes decisions to resolve moderate problems and escalates complex issues to leadership.
• Ensures compliance with Pfizer training and development plans, and models Pfizer values.
• Uses CMC systems like GDMS, PDM, SPA, Rosetta as appropriate.
• Work Location Assignment: Hybrid.

Job description

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.

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Regulatory Affairs