Job Description

Has comprehensive knowledge/understanding of the principles and concepts of the process being followed, to perform the below listed activities but not limited to :

• Manages the day to day work activities associated with assigned renewal applications within agreed upon timelines. Utilizes Pfizer\xe2\x80\x99s systems, i.e. PEARL, GDMS, PDM, SPA, etc., as appropriate.
• Develops renewals regulatory strategy while considering registered content in collaboration with the GRS-CMC & RRHS.
• Preparation of the CMC contributions for Renewal applications for the assigned products for global markets. Authors and/or compiles CMC contributions for renewals, i.e. Module 1, M2.3.S/P, M3.2.S/P/R/A under guidance from the GRS-CMC/RRHS as appropriate and within agreed timelines.
• Coordinates M1/M3.2.R Ancillary documents as needed
• Reviews technical/supportive information for submission to support renewals
• Develops technical justification of change for agency submission as needed
• Supports Query and/or commitment management in collaboration with GRS-CMC
• Liaise with Pfizer Global Supply and other support functions as needed.
• Reviews and applies pertinent regulatory guidelines for authoring renewals.
• Makes decisions to resolve moderately complex problems in standard situations as per the guidance and policies and escalates complex problems / identified risks to the GRS-CMC/RRHS and/or appropriate leadership.
• Maybe responsible for providing technical guidance and mentoring the junior colleagues.
• Responsible for review of Renewals submission package prepared by the colleagues and ensure the quality deliverables as per the defined timeline in the absence of Team lead or designated by Team Lead.
• Serves as a technical lead and responsible for guiding & supporting day to-day renewal activities for the assigned colleagues.
• Responsible for periodic review of renewal process and SOPs. Suggest process improvements if any.
• Responsible for conducting refresher trainings periodically in system and processes associated with

Qualifications

• Preferred Education:

Minimum \xe2\x80\x93 Postgraduate in Pharmacy / Science

• Preferred Experience:

Minimum 9 \xe2\x80\x93 11 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:

• Regulatory requirements of post approval changes for global market.
• Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals.
• Knowledge in retrieving information from company\xe2\x80\x99s and regulatory agency databases.
• Intermediate 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 operates.Regulatory Affairs#LI-PFE

Pfizer