Great opportunity for M.Pharm or MSc as Associate Manager at Pfizer- Apply before 10th November 2023

Job Post: Associate Manager I – Reg CMC Strategy, Brands CMC

Job Description

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’s 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.

Candidate Profile

• 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 are required.
• Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills.

Additional Information

• Experience Required at Pfizer:  6 – 10 years
• Qualification Required at Pfizer: Postgraduate in Pharmacy or Science
• Location: Chennai
• Industry Type: Pharma / Healthcare / Clinical research
• End Date: 10th November 2023

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