Required Drug Regulatory Affairs

Regulatory Affairs LeaderWe are seeking an experienced Regulatory Affairs professional to join our team.The ideal candidate will have extensive experience in managing regulatory affairs for pharmaceutical products, including dossier compilation, submission, and query response. This role requires strong leadership skills, attention to detail, and excellent...

Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to join our team.About the Role:Develop and implement regulatory strategies to ensure compliance with laws and regulations.Collaborate with cross-functional teams to drive business growth and improve operational efficiency.Analyze complex data and information to inform...

Job Title:Regulatory Affairs ManagerWe are seeking a seasoned Regulatory Affairs Manager to join our regulatory team. This role will be responsible for developing and directing global regulatory strategies, leading the preparation of submission dossiers, and collaborating with cross-functional teams.Key Responsibilities:Develop and direct global regulatory...

Job TitleExecutive Leader - Business Development and Regulatory Affairs Specialist.Key Responsibilities:Ensure thorough training before executing assigned tasks.Comply with laboratory safety protocols as per established procedures.Execute characterization activities for drug substances and products using analytical techniques like LCMS, GCMS, ICPMS, and ICP...

Preparation of DMFs for different markets in CTD and eCTD formats.Coordination with cross-functional dept to manage the documents.Supporting marketing team & QC/QA/R&D in various capacity.Preparation of Declarations and other supporting docs. Required Candidate profileCandidate from Pharma - API industry and should have 8+ Years of Experience in Regulatory...

ResponsibilitiesAs a regulatory affairs officer:ensure that a company's products comply with the regulations of the regions where they want to distribute themkeep up to date with national and international legislation, guidelines and customer practicesrespond to queries from medical bodies like the Medicines and Pertaining to that Guidelines.collect, collate...

We are seeking a highly qualified professional to assume the role of Regulatory Affairs Manager in the Medical Device Industry.Job Summary:The ideal candidate will be responsible for ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.Key Responsibilities:Coordinate with regulatory authorities such as FDA and CDSCO for obtaining...

Compilation and submission of eCTD dossier for new product application & post approval submissionQuery response, PAS,CBE and annual report, drug listingReview of artwork and submission of labelling sectionMaintain product life cycle.

Job TitleSenior Executive /Manager 2 – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG11A/G11BLocation :BarodaAt Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.Are You Ready to Create Your Own...

Global Regulatory ExpertWe are seeking a highly skilled Global Regulatory Expert to support end-to-end submissions for global markets.This role requires exposure to Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key Responsibilities:Prepare Variation documents and/or evaluate post-approval changes in compliance...