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The Role
Supports global CMC regulatory strategy, submissions, and compliance activities for commercial pharmaceutical products. Develops post-approval change strategies, prepares regulatory submission information, assesses risks, and creates mitigation plans. Represents CMC on cross-functional teams, interprets regulations and guidelines, manages assigned products, resolves regulatory issues, and escalates complex risks. Uses Pfizer CMC systems including GDMS, PDM, SPA, and Rosetta while maintaining required training and compliance standards.
Summary Generated by Built In
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
#BI-Hybrid
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
#BI-Hybrid
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The Company
What We Do
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.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
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