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.
Post : Manager - Regulatory Conformance
Job Description
Job Summary
• 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.
• Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
Job Responsibilities
• 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.
• Ensures timely communication of any issues e.g. Board of Health queries to the regional teams as needed
• Manages multiple regions/projects/timelines of moderate complexity within a Work Team.
• Manages workload within the team for business continuity
• Work in collaboration with regulatory colleagues to ensure compliance and deliver efficiencies in the regulatory submission process.
• Responsible for evaluation of all CMC notifications for accuracy.
• Responsible for making updates in PDM Market Views for all submission types upon receipt of notification of Submission and Approval evidence
• Applies technical knowledge and key concepts in PDM Conformance updates. Considered as a technical resource within the work team.
• Demonstrates strong technical/functional knowledge w.r.t Regulatory requirements and internal process to coach direct reports on day-to-day activities
• Breadth of technical/functional expertise is focused on applicable discipline
• Acts as a mentor for the colleagues
• Actively shares knowledge with others within Work Team through existing knowledge sharing processes/systems.
• Solves moderately complex problems within area of expertise
• Demonstrates effective written and oral communication skills
• Support for updates in PDM for License withdrawals
• Operate to the highest conformance and quality standards
• Operate in line with internal SOPs and policies
• Encourages the participation and perspectives of all Work Team's members
• Supports developmental and training opportunities for mentees
• 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 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
• Assist in remediation activities
Candidate Profile
• Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.
• 10 to 14 years of experience in a quality or compliance role within the pharmaceutical industry
• General standards, processes and policies of Pfizer / Pharmaceutical manufacturing
• An assertive, take-charge, results oriented, positive “can do” attitude, and a sense of urgency doing things done.
Technical Skills
• Knowledge and / or experience in Pharmaceutical industry in Regulatory / Quality Assurance, especially in Life cycle management or compliance.
• Strong quality and compliance orientation
• Diligence and attention to detail
• Prior Regulatory experience in any of the market
• Knowledge of regulatory practices, rules, regulations and guidelines
• Good communication skills
• Problem Solving
• Understanding stakeholder needs
• Fluent English Speaker
Additional Information
Experience : 5+ years
Qualification : Degree in Chemistry, Pharmacy
Location : Chennai
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Regulatory Conformance
End Date : 10th September, 2023
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