Associate I: Regulatory Conformance Job in Chennai at Pfizer

Pfizer is hiring for the role of Associate I: Regulatory Conformance!

Responsibilities:

• Committed to quality and excellence in compliance and conformance
• With a reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned.
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Contributes independently and manages own time to meet the timelines.
• Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
• Independently Perform accurate updates in the system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
• Makes informed decisions on straight cases within guidelines and policies
• Support for updates in the system for License withdrawals
• Operate in line with internal SOPs and policies
• Adhere to standard turnaround timelines
• Escalate any potential compliance issues to management
• Support periodic and ad-hoc system reports to estimate metrics
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
• Assist in ensuring internal regulatory processes and procedures are well-documented
• Assist in remediation activities
• Support the teams in ADHOC activities
• Share the learning from time to time with the team colleagues

Requirements:

• Theoretical Knowledge of Regulatory Affairs / Compliance
• Experienced in Regulatory / Quality Assurance/ Production or any other functions in Pharmaceutical or related industries
• Diligence and attention to detail
• Good communication skills
• Understanding stakeholder needs
• Preferred Year Of Experience - 2 to 4 years of experience
• Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences