Executive / Sr. Exe - Regulatory Affairs - EU/UK -Pharma only - Mumbai

Job Title: Regulatory Affairs ManagerAbout the RoleThis is an exciting opportunity for a highly skilled Regulatory Affairs professional to join our organization and contribute to the success of our team. We are seeking an experienced Regulatory Affairs Executive to lead our regulatory strategy, manage regulatory submissions, and maintain strong relationships...

RESPONSIBILITIESCompilation of modules 1, 2 and 3 of Initial Marketing Authorization Applications for EU and/or UK. Experience with AUS-NZ submissions would be an added advantage.Publishing in eCTD format and submission to respective Regulatory Agencies.Compilation and submission of variation applications for EU and/or UK.Review of documents related to...

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 /...

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...

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...

Regulatory affairs specialists play a vital role in ensuring compliance with regulatory requirements and facilitating the smooth operation of businesses.This position requires an individual with expertise in regulatory affairs, including experience with eCTD software and e-publishing requirements throughout the project lifecycle. The ideal candidate will...

Role & responsibilitiesNew submissions Preparation, Registration & Submission of Dossiers to EU or UK and other regulated markets.Compilation and review of Type IA/IB/II Regulatory Variations.e.CTD publication of variation applications/PIQ/Renewal/New applicationsPreparation/Submission of Change of Ownership applications, Piggyback application etc.Submission...

Review, Compilation of Dossiers for US/EU/AUS Market Prepare, compilation, review and submission of ANDA Review of Annual Report Compliance checks and review regulatory documents Other related activities Required Candidate profileApplicant must be having 3 - 8 years of experience in Regulatory Affairs (Formulation) in leading pharma company. Well versed...

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...

Job Title:Senior Executive / Assistant Manager – Regulatory AffairsLocation:Mumbai, India (On-site)Employment Type:Full-time | PermanentExperience Required:3 to 8 yearsIndustry:Chemicals | Pharmaceuticals | Food & BeveragesJob Function:Legal | Quality Assurance | Regulatory AffairsSalary: up to 9 LPAAbout the Role:We are hiring for a Senior Executive /...