Officer / Sr. Officer - Regulatory Affairs EU/UK

Dear All,We are seeking a proactive and detail-oriented Regulatory Affairs professional to join our dynamic teamRole & responsibilitiesPreparation of CTD dossiers for Regulated manket [EU/UK/TGA].Co-ordination with Plant, R&D & ADL to collect inputs required for Regulatory submission.Variation filling.Timely achievement of monthly plan.Interpretation and...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...

RESPONSIBILITIESCompilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU, UK and AUS-NZ. Publishing in eCTD format and submission to respective Regulatory Agencies.Compilation and submission of variation applications for EU, UK and AUS-NZ.Review of documents related to compilation of dossiers and query responses.Up to date...

UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.e., Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufacturing facility, located in Vapi (Gujarat). Facility is accredited by global regulatory agencies like EU, PICs, Local FDA and Inspected by USFDA.UMEDICA was...

About your roleWe have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Executive/Sr. Executive. This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.Your key responsibilitiesResponsible for preparation / checking /...

Job Title / Designation Office Regulatory AffairsOrganization Name Kremoint Pharma Pvt. Ltd.Job Location VikhroliJob Description / ResponsibilitiesPrepare and compile dossiers for CTD, ACTD, and country-specific requirements for in-house, loan license, and third-party products for the ROW market.Apply for Free Sale Certificate (FSC) and Product Permission...

Designation:Regulatory affairs -Executive/ Sr. ExecutiveJob Location:MumbaiJob Summary:The primary responsibility for the position is to oversee the daily activities of the Regulatory Affairs. Ensure that deliverables are being met based on planned submission timelines. Directs the development of submission of Product registration Dossiers, amendments, PSUR...

* This is a Temporary position for a period of 6-8 months.Location: Andheri, Mumbai(Hybrid working opportunity)About ADVANZ PHARMAADVANZ PHARMA is a global pharmaceutical company with the purpose of improving patients' lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on.Our ambition is to be a partner of choice...

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables...

Job Title: Regulatory AffairsNo of Vacancy: 1Job Location: Andheri WestYears of Experience: 1-4 yearsWorking Days: Monday to SaturdayJob Summary:We are seeking a motivated and detail-orientedRegulatory Affairs Executiveto join our team. The ideal candidate will be responsible for preparing and maintaining regulatory documentation to ensure compliance with...