Associate I Reg Cmc Strategy Brands Cmc Job In Pfizer Asia Pacific Pte Ltd In Chennai, India

Manages day-to-day regulatory activities associated with assigned Renewals within agreed upon timelines under the guidance of Team Lead / designeeHas fundamental knowledge of the principles and concepts of process been followed, the activities which includes but not limited to:

• Provides support to renewal strategist in preparation of the CMC contributions for Renewal applications for the assigned products for global markets
• Authors and/or compiles CMC contributions for renewals, ie, Module 1, M2.
  
  3S/P, M32S/P/R/A Collaborates with GRS-CMC/RRHS as appropriate and within agreed timelines.
  
  
• Liaise with Pfizer Global Supply and other support functions as needed
• Applies pertinent regulatory guidelines for authoring renewals
• Executes renewals regulatory strategy while considering registered content and seeks endorsement by the GRS-CMC/RRHS
• Reviews technical/supportive information for submission to support renewals
• Updates impacted dossier components as needed.
  
  Escalates delays in timelines and contributes to the Identification and mitigation of risks with the support of TL/designee flags identified risks to the CMC GRL and/or appropriate leadership
• Coordinates M1/M32R Ancillary documents as needed
• Coordinates internal document review and sign off.
  
  
• Utilizes Pfizer's systems, ie PEARL, GDMS, PDM, SPA, etc, as appropriate

• Preferred Education: Minimum - Undergraduate/Postgraduate in Pharmacy or Science

• Preferred Experience: Minimum 0 - 1 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical Organization

• Preferred Attributes: Excellent oral and written English communication skills.
  
  Good conceptual, analytical, problem solving, and organizational skills Good conceptual and reasoning skills Attention to details

• Technical Skills:
• Knowledge on Regulatory requirements of post approval changesfor global market
• Knowledge in retrieving information from company's and regulatory agency databases.
  
  
• Basic level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry

Work Location Assignment:FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operatesRegulatory Affairs#LI-PFE

Pfizer Asia Pacific Pte Ltd is looking for .

Pfizer Asia Pacific Pte Ltd is looking for Any Graduate / Post Graduate profile candidates.