Associate- Drug Regulatory Affairs_US_

Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for US Markets.Key...

Job PurposeWe are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support global regulatory submissions and lifecycle management for pharmaceutical products. The ideal candidate will have hands-on experience with CTD/eCTD documentation, regulatory compliance, and dossier preparation, particularly for Canada Markets.Key...

Area Of ResponsibilityTo review quality and manufacturing end data for various in-house developed APIs for regulatory adequacy for compilation of Drug Master Files/Registration Dossiers, Amendments/Variations, Technical Data Package/Open Parts of DMFs for In-House developed APIs and their updation to meet current regulatory requirements.To review outsourced...

Responsibilities:* Prepare regulatory dossiers for product approvals* Collaborate with cross-functional teams on dossier updates* Ensure compliance with drug regulations according to NAFDAC standards.* Manage LOAs, COAs & BDNAF submissions

Full TimeGurgaonPosted 1 hour agoTeam Lead–Medical Writing-Drug Safety & Reg AffairsExperience: – 5+ YearsLocation: Gurgaon (On-site)Job purposeTo plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory GuidelinesRoles & ResponsibilitiesProviding high-quality medical and...

Team Lead–Medical Writing-Drug Safety & Reg AffairsExperience:– 5+ YearsLocation:Gurgaon (On-site)Job PurposeTo plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to applicable regulatory and Regulatory GuidelinesRoles & ResponsibilitiesProviding high-quality medical and scientific writing from planning and...

We're hiring Looking for an energetic Regulatory Affairs professionals join our team in Gurgaon.Job SummaryRegulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of ResponsibilityNew submissions:a. Review & prepare CMC...

Job Summary Regulatory submission of new products, variations, response to queries, Life cycle management for US and OAM region through preparation of quality dossiers enabling timely approvals.Area Of Responsibility1. New submissions:a. Review & prepare CMC (Chemistry, Manufacturing and Controls) dossiers for fresh submissions.b. Review documents...

Role & responsibilitiesYou will lead the regulatory activities for all Convatec products including product registration (new, renewal and amendment), product promotional activities, labeling review activities, product registration and listing database.Location: GurgaonKey duties and responsibilitiesDevelop regulatory strategy and update the strategy based...

Onboarding Specialist will be responsible for getting an employee onboarded and getting their Drug Test and Background verification processed along with their badging and sharing of credentials with employee and coordinating with HR team for employee orientation.PRINCIPAL ACCOUNTABILITIES - BGV, DT & BadgingMajor Activities -Gather and process paperwork,...