Founded in 1849, 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 : Trainee Executive
Job Description
Role Summary
• Delivery of electronic and paper regulatory transactions in support of New Product Launches, Legalizations, and License maintenance (eg, COPP , GMP , FSC certifications etc) • Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities (e.g. legalizations) Subject matter expert of Pfizer’s positions in support of proposed changes
Responsibilities
• Delivery of Product License Support Portfolio
• Identify opportunities and implement solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
• Knowledge share and educate personnel as appropriate on agency requirements and guidelines.
• Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.
• Process development and change management in the context of PLS submissions
• Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution
• Utilization support of electronic technologies for submissions and tracking of documentation
• Matrix management of cross-functional teams as appropriate
• Development and maintenance of documented procedures and guidelines as necessary
Primary Responsibilities
• Delivery of Product License Support Portfolio
• Identify opportunities and implement solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
• Knowledge share and educate personnel as appropriate on agency requirements and guidelines.
• Lead or participation on global/local teams to complete assignments and tasks within a specific task force/project.
• Process development and change management in the context of PLS submissions
• Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution
• Utilization support of electronic technologies for submissions and tracking of documentation
• Matrix management of cross-functional teams as appropriate
• Development and maintenance of documented procedures and guidelines as necessary.
Candidate Proflie
• Technology : Experience and competency with Regulatory software, Document Management, regulatory milestone reporting tools.
• Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines
• Demonstrated fluency with regulatory submissions and understanding of application of technologies.
Additional Information:
Functional Area : Training
Location: Chennai
Education: B.Pharm / MPharm, MSc
Industry Type: Pharma/ Healthcare/ Clinical research
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