Manager - Reg CMC Strategy, Brands Clinical Program Support

Job Description

locations India - Chennai time type Full time posted on Posted 4 Days Ago job requisition id hidden_mobile Job Summary (not all inclusive):Functions as a CMC Regulatory Strategist working with Global Regulatory Strategists (GRS-CMC) and Cross Functional Teams to prepare and submit CMC strategies/ submissions for the assigned activities/products in support of clinical program. The regulatory activities may include authoring /supporting CMC strategies & CMC contents for IND/IMPD/ROW IMPDs & NDA/MAA/ ROW dossier independently and in support of Global team. Provide operational global CMC regulatory support and documentation for assigned projects/products covering initial registrations and approval activities of various complexities / risks. Perform regulatory fact finding for the preparation of CMC information for submission to global regulatory agencies. Maintain CMC systems and perform data management. Also, responsible for complete review of the assigned CMC submissions packages and associated system-based tasks. Provides mentoring/training support for junior staffs.Job Responsibilities:Functions as a CMC -Regulatory strategists responsible for the assigned CMC activities of various complexity/risk related to clinical development programs with in Global Brands. The responsibilities include, but not limited to the following:To work with PCO and RRHS so that RRM remains updated with the current requirements.Provide review support of the assigned CMC submissions authored by other teammembers.Assist in gathering and interpreting global clinical submission CMC requirements usingsystems and/or in collaboration with country regulatory leads for the development ofregulatory strategy.May develop/support authoring regulatory strategies for global/regional markets for theassigned programs/products to support registrations.Assist in authoring IND / IMPD/ NDA/MMA and ROW CMC dossiers andsubmissions activitiesIndependently author ROW IMPD CMC dossiers in close collaboration with the CMC Leadand coordinate quality review according to internal procedures as well as sign-offprocedures (Reg-456/459 reviews).Assist in collection of supporting documentation from Pharm Sci, PGS, etc. Identify therequired documentation and any content, quality and/or timelines issues for globalsubmissions and negotiate the delivery of approved technical source documents inaccordance with project timelines.Support CMC systems maintenance and publishing activities (e.g. SPA, PDM, etc).Liaise with RCM as needed.Support clinical CMC activities for the existing portfolio, e.g., CMC activities to support BE,pediatric development, etcContribute to the completion of projects, manage own time to meet agreed targets anddevelop plans for short-term work activities on own projects within a work team.Ensure compliance of the team to the submission standards, procedures and policiesframed by Global Regulatory Affairs.Assess scientific opinions and assist in developing regulatory strategies anddocumentation.Recommend solutions for issues of various complexities and escalates issues withsignificant business impact where necessary.Assist in the development of resolution proposals for moderate regulatory CMC/informationmanagement issues in support of project/program stakeholders.Updates ancillary document requests in appropriate system, as needed.Provides mentoring/training support on technical aspects of the team (end to end, fromstrategy building through authoring submissions), Pfizer System and processes to juniorstaffs.Preferred Education:Minimum - Postgraduate in Pharmacy or SciencePreferred Experience:Minimum 9 + years of CMC experience within a regulatory function with knowledge of INDs/IMPDs, NDAs, ANDAs, MAAs, CTDs and other regulatory components.Work Location Assignment: On PremiseWork Location Assignment: On PremisePfizer 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,

Keyskills :
equal employment opportunityregulatory affairsfact findingdigital conversion