Senior Executive - Regulatory AffairsFerring Pharmaceuticalsfull-timeRequired skillscompliancecross-functionalAbout the role Ferring Pharmaceuticals Website: ferring.com Job details: Job Description:Key ResponsibilitiesRegulatory Submission & Licensing ActivitiesExecute regulatory submission activities within agreed timelines for Central and State regulatory authorities.Prepare and submit:Import Licenses (Form 12 and CT-16) through NSWS portalCDSCO NOCs (CT-10, CT-12 & CT-13) via NSWS portalTest Licenses (Form-29) through State FDA online portalsCT-21 applications for Clinical Trial and Marketing AuthorizationCT-05 (BA/BE) applications via SUGAM portalWHO-GMP applications through ONDLS portalHandle applications for:Manufacturing LicensesAdditional Product LicensesLoan LicensesGMP, GLP, COPP, FSC, Non-Conviction Certificate, EU WC, WHO-GMP certifications, etc.Coordinate with CDSCO, State FDA, CROs, CMOs, and other regulatory authorities/agencies for timely approvals and compliance.Dossier Preparation & Documentation ReviewPrepare, compile, review, and submit dossiers for Marketing Authorization (MA) applications in India and other markets.Prepare briefing packages for scientific advisory meetings and product/site registrations.Review and evaluate:CMC documents including Drug Substance & Drug Product dataBMRs, Specifications, COAs, Process Validation Protocols/ReportsDMFs, development reports, validation plans, and manufacturing documentsArtwork components such as labels, cartons, and package insertsNon-clinical pharmacology and toxicology dataClinical trial and BA/BE study documents and protocolsEnsure dossiers comply with current regulatory requirements and internal quality standards.Regulatory Compliance & Query ManagementDraft, review, and submit responses to regulatory authority queries within stipulated timelines.Conduct gap analysis and risk assessment based on available data/documents and evolving regulatory guidance.Monitor submission and approval status to ensure product registrations meet business and launch timelines.Ensure compliance with applicable regulatory requirements, company SOPs, and global regulatory policies.Maintain accurate documentation, tracking systems, and regulatory databases.Cross-Functional CoordinationCoordinate with QA, QC, R&D, Manufacturing, Clinical, Pharmacovigilance, CROs, and CMOs for timely preparation and submission of regulatory documents.Support new product development initiatives with fit-for-purpose regulatory strategies.Ensure effective communication with internal stakeholders regarding submission status, regulatory updates, and compliance risks.Pharmacovigilance ResponsibilitiesPerform pharmacovigilance case processing activities within agreed timelines.Ensure proper handling and reporting of safety data in compliance with applicable pharmacovigilance regulations.Required Education & ExperienceM. Pharm / MSc / Equivalent in Pharmacy or Life Sciences from a reputed university.Minimum 5 years of industrial experience in Regulatory Affairs.Hands-on experience in India regulatory submissions and exposure to other international markets preferred.Location:Ferring India FHPDC R&D Click on Apply to know more. This page is fully interactive when JavaScript is enabled. Please enable JavaScript to apply or browse related roles.