Awareness, understands, and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. Makes sound technical decisions, and appropriately communicates these decisions to other scientists and management.
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 : Associate I – Regulatory Conformance
Job Description
Job Summary
• Committed to quality in compliance and conformance
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Manages the day to day work by self with periodic supervision by the Lead/Designee
Job Description
• Committed to quality and excellence in compliance and conformance
• With the 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 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 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
• Shares the learning time to time with the team colleagues
Technical Skills
• Theorotical Knowledge on 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
Candidate Profile
Standards, Processes and Policies - General standards, processes and policies of Pfizer Behavioural/Any other Skills – An assertive, results oriented, positive “can do” attitude, and Time management skills.
Preferred Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. Preferred Year Of Experience - 2 to 4 years of experience Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferrable.
Additional Information
Experience : 2 to 4 years
Qualification : Master’s / Bachelor’s degree or equivalent
Location : Chennai
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Regulatory
End Date : 20th August 2024
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