Pfizer Regulatory Affairs Recruitment – Assistant Manager Post

Pfizer Regulatory Affairs Recruitment – Assistant Manager Post

They looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward-thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient access to Pfizer medicines and vaccines.

Job Title: Assistant Manager – Regulatory Affairs

Location: India – Chennai

Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or related life sciences. Preferred Year Of Experience – 6 to 9 years Type of Experience – Demonstrated regulatory or quality or any relevant experience within a Pharmaceutical / Lifesciences Industry. Proven ability to consistently deliver to high-quality standards and timelines.

Technical Skills –

• Knowledge and/or experience in Regulatory / Quality /Compliance any other relevant functions within Pharmaceutical Industry
• Strong quality and compliance orientation
• Knowledge of regulatory practices, rules, regulations, and guidelines
• Diligence and attention to detail
• Good communication skills
• Understanding stakeholder needs

Standards, Processes, and Policies –

General standards, processes and policies of Pfizer/Pharmaceutical Industry
Behavioral/Any other Skills –

An assertive, take-charge, results-oriented, positive “can do” attitude and has a sense of

urgency as appropriate

Job Responsibilties: 

• Committed to quality and excellence in compliance and conformance
• Accountable for maintaining the corporate change and dossier management system (PDM) regarding the status of regulatory CMC submissions with global health authorities per internal SOPs and policies.
• Contributes to the completion of PDM updates independently
• Manages own time on deliverables
• Responsible for the evaluation of all CMC notifications for accuracy.
• Ensures all the gaps are being addressed in line with the defined processes and the current regulations
• Responsible for making updates in PDM Market Views for all the CMC events upon receipt of notification of Submission and Approval evidence
• Contributes to the deliverables of the complex cases with the guidance of Team Lead / Designee
• Applies technical knowledge and key concepts in PDM Conformance updates.
• Exercises own judgment utilizing the breadth of knowledge and prior work experience, in agreement with TL/Designee
• Uses the knowledge to provide ideas towards excellence in the Conformance activities
  Provides guidance to colleagues while handling the complex notifications as needed
• Acts as a technical guide for the colleagues for specific regions
• Considered as a technical SME for selected markets / Products
• Performs random QC checks to improve the efficiency of the team
• Supports in ADHOC activities / Withdrawal activities as necessary
• Operate to the highest conformance and quality standards
• Operate in line with internal SOPs and policies
• Adhere to standard turnaround timelines
• Escalate any potential compliance issues to management
• Liaise with regulatory colleagues and ensure timely escalations to address the potential issues
• Provide input to continuously improve and streamline the process
  Contribute to local and regional regulatory initiatives by establishing a culture aligned with Pfizer values and which supports compliance.
• Ensures to utilize the internal tracking system efficiently to manage self and contribute to overall metrics management for the team.

Job Summary: 

Committed to quality and excellence in compliance and conformance
Accountable for maintaining the corporate change and dossier management system (PDM) health authorities per internal SOPs and policies.
Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process

Apply Online

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