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Manager Reg CMC Strategy, NP CMC Support

3.00 to 7.00 Years   Chennai   07 Nov, 2022
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Operations Management
EmploymentTypeFull-time

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 and Annual Reports within agreed upon timelines. Utilizes Pfizers 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 and Annual Reports for the assigned products for global markets. Authors and/or compiles CMC contributions for renewals and Annual Reports, 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 neededReviews technical/supportive information for submission to support renewals and annual reportsDevelops technical justification of change for agency submission as neededSupports Query and/or commitment management in collaboration with GRS-CMCLiaise 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 and Annual Reports 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 and annual report activities for the assigned colleagues.Responsible for periodic review of renewal/annual reports process and SOPs. Suggest process improvements if any.Responsible for conducting refresher trainings periodically in system and processes associated with the renewals and annual reports.QUALIFICATIONS / SKILLSIndicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience, licenses, certifications, and other job-related technical and managerial skills.Preferred Education: Minimum Postgraduate in Pharmacy / SciencePreferred Experience:Minimum 9 11 Years in leading independently in the Regulatory Affairs function in a reputed Pharmaceutical OrganizationPreferred 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 markets.Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape.Oral Solid Dosage form and sterile injectable manufacturing and regulatory data requirements for submission of License Renewals and Annual Reports.Knowledge in retrieving information from companys and regulatory agency databases.Intermediate level of knowledge on general standards, processes, and policies of Pfizer/Pharmaceutical manufacturing Industry.,

Keyskills :
PEARLSPAGRSCMCRRHSGDMS

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