Job Description

• Minimum - Postgraduate in Pharmacy or Science (Graduates can be considered based on exceptional merit).
• Minimum 6 - 10 years of CMC experience within a regulatory function. 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.

• General

Development and execution of CMC strategies for post approval changes globally in collaboration with global and regional counterparts. * Liaise with cross functional teams and other support functions as needed.

• Use of regulatory systems and management of CMC documentation and information.

Specific

• Manages day-to-day regulatory activities associated with projects assigned.
• Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content in partnership with global and regional counterparts.
• Authors and/or compiles Regulatory Strategy Documents (RSD) where needed, as well as CMC submission packages(Supplements /Variations) globally, i.e.Module 1, Module 2.3, M3.2S/P/R 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.
• Flags identified risks to appropriate leadership.

• Represents RA CMC point of view and meets with key stakeholders to resolve challenges.
• Coordinates internal document review and sign off.
• Utilizes Pfizer\xe2\x80\x99s CMC regulatory systems, as appropriate.
• Supports Query and/or commitment management in collaboration with global counterparts.
• Maintains conformance systems maintenance in support of global counterparts.

Work Location Assignment: On Premise

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

Regulatory Affairs

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Pfizer