Job Summary

Functions as the primary CMC strategist for the Life Cycle Management (LCM) activities of assigned products and/or projects  providing regulatory assessments and developing regulatory strategies.

Acts as the global CMC representative within cross-functional project teams.  Accountable for assigned projects and activities, completing work within assigned product portfolio. Develops resolution proposals for regulatory CMC issues with the stakeholders with the guidance of Team Lead. 

Reviews proposed CMC changes for completeness and accuracy, interpret CMC regulatory requirements , develops strategies, assess risks and develops contingency proposals.  Use technical and scientific knowledge to conduct the analysis of CMC submission documentation.

Responsible for the authoring of CTD sections (Module 3 and QOS) and review of CMC documentation, coordination and management of global submissions, including the assessment and management of commercial license status, maintenance of product compliance and management of change control.  

Job Responsibilities

·       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, etc, as appropriate

• Preferred Education:

Minimum – Postgraduate in Pharmacy / Science

• Preferred Experience:

Minimum 6 Years in Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling post approval changes for Global markets. Experience in filing of Oral Solid Dosage form and Sterile injectables submissions are preferable.

• Preferred Attributes:

Excellent oral and written English communication skills. Good project management and strategic problem solving skills. Sound interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities. Well-organized and accustomed to maintaining excellent records.

• Technical Skills:

Reasonable knowledge in the regulatory requirements of post approval changes for global markets including ICH guidance.

Sufficient level of knowledge in handling post approval changes of Solid Oral Dosage forms and/or sterile injectable manufacturing and regulatory data requirements for managing Global post approval submissions.

Knowledge in retrieving information from company’s and regulatory agency databases.

Good level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

  
Work Location Assignment: Flexible

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Regulatory Affairs#LI-PFE