Work as Regulatory Affairs Assistant Manager at Pfizer
Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Assistant Manager - Regulatory Affairs
• 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 for PEH products.
• Ensures timely communication of any issues e.g. Board of Health queries to the regional teams as needed
• Work in collaboration with regulatory colleagues to ensure (GRL, RRL, CRL & RCM) compliance and deliver efficiencies in the regulatory submission process.
• Responsible for making updates in PDM Market Views for all submission types except those processed via the MRP/DCP/CP procedure upon receipt of notification of Submission and Approval evidence
• Providing accurate updates in PDM and consult with concerned colleagues for clarification of any discrepancies, before updating PDM.
• Support for updates in PDM for withdrawals of products registered via MRP/ DCP/ CP
• Operate to the highest conformance and quality standards
• Operate in line with internal SOPs and policies
• Manage status updates of global CMC submissions for the PEH portfolio within the corporate change and dossier management system
• Adhere to standard turnaround timelines
• Escalate any potential compliance issues to management
• Liaise with regulatory colleagues to communicate and resolve potential issues
• Provide input to continuously improve and streamline the submission process
• Support periodic and ad-hoc system reports to estimate metrics
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
• Assist in ensuring internal regulatory processes and procedures are well documented
Qualification : M.Pharm, M.Sc, B.Pharm
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 25th December, 2019
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