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Senior Manager - Regulatory Affairs - Biologics - Pharma

10.00 to 20.00 Years   Mumbai City   05 Feb, 2022
HR Cornucopia Pvt Ltd
Job LocationMumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryRecruitment Services
Functional AreaOperations Management / Process Analysis
EmploymentTypeFull-time

Job Description

    We are urgently looking for Sr Manager - Regulatory Affairs - Biologics for one of the reputed Pharma Company which is based out of Mumbai.1. Product Development Regulatory support- Work with RDPM to highlight risks to the project and suggest risk mitigation strategies- Provide recommendations for the product development activities in line with current regulatory expectations- Review all documents related to product development including CMC/preclinical/clinical development.2. Regulated market submissions- Prepare and submit applications for (pre)-clinical trial/marketing authorizations dossiers to customer / Health Authorities and subsequently follow-up for approval.- Archive all communications with customers, consultants and regulatory agencies- Review content sufficiency and accuracy of (pre)-clinical trial operational plans, deviations, proposals, protocol, IB- Support for medical device development, including assistance in premarket approval (PMA) submissions to FDA- Provide, review and approve the content for product information (SmPC/PIL/Label)- Send notification to customers for changes3. Domestic/Emerging market submissions and support- Submit Registrations, Re-registrations, (Pre)Clinical trial applications, amendment and Tender (country specific) dossiers- Initiate request for preparing separate set of documents basis the targeted market by making checklist and sharing with cross functional departments- Keep track of test licenses/manufacturing licenses/GMP certifications and ensure renewal of the same time to time. Coordinate with licensing team for issuance of the same- Receive finished packs along with COA to enable filing of dossier - Arrangement for registration/reregistration samples- Support preparation and approval of new artwork. Archive approved copies- Prepare Regulatory requirements map of biologicals/biosimilars for Emerging market countries and updating the same- Prepare and file applications for test licenses/Test license NOC/Export NOC/product permissions/marketing authorization for drug substance and product- Archive all submissions.4. Plant related activities and RA support- Review and approve change controls/ deviations/OOS for drugs and products (with thorough assessment of impact on product quality and regulatory submission)- Review quality agreements with regulatory perspective- Participate in plant meeting and keep self updated with ongoing product development activities/strategies- Review SMF, VMP, SOPs, study reports, etc.- Preparing for and participating in GMP/marketing authorization audits of facility and for due-diligence/client visits- Update cross functional teams regarding regulatory/quality guidance/other relevant information- Coordinate with the plant and R&D for various documents required for review and RA archival.,

Keyskills :
environmental impact assessmentproduct qualityregulatory requirementsfinancemisaccountancyrisk mitigationstudy reportsdevice developmentproduct developmentpremarket approvalregulatory affairs

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