Regulatory Affairs Specialist

Role & responsibilitiesResponsible for Drug Master Filing submissions to various regulatory agencies like USFDA, European Agencies, Brazil, and other semi-regulatory countries.Review and submission of Response to queries raised on DMF by USFDA, and other agencies.Review and submission of Amendments and revisions of Drug Master Files.Review and ensuring the...

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...

Responsible for Regulatory Affairs functions at Exemed Pharmaceuticals Luna.Responsible for Issues Letter of Access, Letter of commitment and CEP certificate for customer as per specific regulatory requirement.To prepare commitment, Declaration and Statement certificate for customer as per specific regulatory requirement.Responsible for prepare and review...

Job TitleExecutive – Regulatory AffairsBusiness UnitR&D1 Regulatory AffairsJob GradeG12ALocationBarodaAt 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 Sunshine? As you enter the Sun...

Company Name: Exemed PharmaceuticalsDesignation - Drug Regulatory Affairs -Officer/Sr OfficerLocation - Vadodara ( Corporate Office)Market: DomesticPrimary Job DescriptionsHaving knowledge of SUGAM portal and CDSCO websiteSubmission for Mfg. & Mkt. Applications [CT21/CT-18] for IND, New Drug, Subsequent New Drug, FDC.Application of CT-05 / CT- 04Application...

Job Title Executive - Regulatory Affairs Business Unit R D1 Regulatory Affairs Job Grade G12A Location Baroda At 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 Sunshine As...

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.Job Types: Full-time, PermanentPay: ₹600, ₹800,000.00 per yearBenefits:Food providedHealth insuranceProvident...

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...

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.

Internship in Quality Control (QC)/Quality Assurance (QA)/Production/Regulatory Affairs in Pharmaceutical CompanyM.Sc./B.Sc/ M.Pharm/B.Pharm