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, PLMDS - GRRS
• Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
• Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,
• Delivery of Product License Support Portfolio in a timely and quality manner.
• Contributes to the completion of project tasks and/or milestones
• Organizes own work to meet project task deadlines
• Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
• Has fundamental knowledge of the principles and concepts of the discipline.
• Applies technical skills to achieve assigned tasks
• Contributes to the completion of routine Work Team related tasks.
• Uses technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
• Applies fundamental knowledge of the relevant regulatory industry and local business environment.
• Has fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
• Makes decisions that require choosing between limited options toresolve problems basic in their complexity
• Performs work in a structured environment under direction from supervisor
• Decisions impact own work and have limited effect on projects.
• Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.
• Exercises judgment to complete assigned tasks and has significant reliance on supervisor
• Works in a structured environment under direct supervision
• Uses established procedures to perform assigned tasks
• Asks for guidance from other colleagues
• Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
• Communicates straightforward information, asks questions and checks for understanding
• Participates and contributes as a team member
• Is responsible for certain team deliverables
• Bachelor's Degree
• Demonstrated experience
• Relevant experience in electronic submissions build within the Pharmaceutical Industry
• Demonstrated coordination of activities in a highly regulated environment
• Demonstrated experience working in a challenging customer service environment
• Knowledge of the drug development process
• In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation
• Good knowledge of English, spoken and written
Qualification : Bachelor's Degree
Location : Chennai
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : PLMDS - GRRS
End Date : 31st August, 2023
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