Regulatory Affairs Executive/Sr Executive- EU/UK/AUS-NZ

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...

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...

Experience- 5 to 7 YrsRESPONSIBILITIES- Compilation 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...

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...

Experience- 5 to 7 Yrs RESPONSIBILITIES Compilation 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...

Experience- 5 to 7 Yrs 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...

Our Regulatory Affairs Executive will lead the compilation of marketing authorization applications for EU, UK and AUS-NZ in eCTD format. They will submit these to respective regulatory agencies. Additionally, they will compile and submit variation applications for the same regions.">Responsibilities:Compile modules 1, 2, and 3 of Initial Marketing...

Note: Walk In Interview at MumbaiDate: Saturday)Designation:- Sr. Executive/ Executive /Sr. Officer / OfficerQualification:- M.Sc / M.PharmExperience:- 2 to 11 YearsJob Location:- Mumbai Required Candidate profile2 -11 years of experience in pharmaceutical regulatory affairs, guidelines including FDA, EMA, and ICH regulations.Market : US, Europe, South...

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...

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...