Associate I - Regulatory Change Manager Job in Chennai at Pfizer

Pfizer is hiring for the role of Associate I - Regulatory Change Manager!

Responsibilities of the Candidate:

• Providing operational support within the Regulatory Change Management (RCM) team to execute designated tasks associated with CMC/Regional colleagues.
• Packaging coordination activities for assigned products and/or at required CMC change management Process as appropriate.
• Accountable for delivering tasks with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.
• Adhering to the appropriate use of technical tools, through the use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.
• Escalating, informing, and/or resolving any issues that may impact the timeline, quality, or compliance of submissions.
• Has Fundamental knowledge and skills of regulatory CMC submissions and ensures regulatory or business requirements are fulfilled.
• Committing to completing required on-the-job training courses to ensure training compliance is preserved.
• Promoting the use of Document Management systems and standard document publishing processes, partnering with supplier groups as necessary to produce timely delivery of submission-ready components.
• Executing regional-specific CMC tasks to support on-time project delivery.
• Able to operate at pace with agile decision-making skills. Uses evidence and applies judgment to balance pace, rigor, and risk.
• Commanding necessary knowledge and skills for on-time delivery of CMC submissions ensuring business requirements are fulfilled.
• Accountable for delivering category-aligned submissions with quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines, or service level agreement.

Requirements:

• Bachelor's Degree in Pharmacy, Biotechnology, or Science background.
• Demonstrated 0-2 years of experience.
• Relevant experience in electronic submissions built 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.
• Experience in project management.
• Master’s Degree in Pharmacy, Biotechnology, or Science background.