Regulatory Affairs Executive

Executive Officer Drug Regulatory Affairs (DRA) Job Posting: 10/11/2021 Panchkula JOB REQUIREMENTS Mandatory Qualifications Work Experience in Relevant Field 2.5-5 Years Technical Skills Required Who You'll Work With Regulatory Authorities What You'll Do Registration of new pharmaceutical drug Product.Renewal of approval of existing drug products....

Role & responsibilitiesJob Summary:We are looking for a skilled and motivated Senior Executive Drug Regulatory Affairs to support the registration and maintenance of injectable pharmaceutical products across ROW (Rest of the World) markets. The ideal candidate will have experience in compiling and submitting dossiers in accordance with country-specific...

Role & responsibilitiesRegulatory Submissions and Approvals:Prepare and submit dossiers for product registrations in ROW, Africa, LATAM, CIS, and ASEAN markets, ensuring adherence to country-specific guidelines and requirements.Coordinate with internal departments (R&D, Quality Assurance, Production) to compile the necessary technical documentation for...

**Full job description** - Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats. - Filing annual updates and amendments to various regions of submitted DMFs. - Handling queries obtained from different regulatory agencies and customers. - Generation of documents from R&D, Production, QC...

Assist in the preparation and review of regulatory dossiers in CTD/eCTD formatfor submission.Support in the compilation of documentation for New MarketingAuthorizations, Post -Approval Variations, and Renewals.Coordinate with departments such as QA, QC, Production, R&D, andPackaging for data collation and timely submission.Review and verify product labeling,...

**Full job description** - Compilation, preparation, and review of DMFs for US, Europe, Canada and ROW markets in specified eCTD or NeeS or CTD formats. - Filing annual updates and amendments to various regions of submitted DMFs. - Handling queries obtained from different regulatory agencies and customers. - Generation of documents from R&D, Production, QC...

EXPORT Manager /Assistant Manager Regulatory Affairs Expertise: Asian & African Countries 1. Regulatory Strategy & Compliance Develop and implement regulatory strategies to ensure timely approvals for new products, variations, and renewals. Ensure compliance with national and international regulatory requirements (e.g., PIC/s, EMA, WHO, ICH,...

Position Title: Chief Exports Officer (International Business)Job Description: Chief Exports OfficerLocation: Chandigarh/Panchkula | IndiaReports To: International Business LeadershipTeam Leadership: All International Business teamsOur Company:We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately...

Position Title: Chief Exports Officer (International Business)Job Description: Chief Exports OfficerLocation: Chandigarh/Panchkula | IndiaReports To: International Business LeadershipTeam Leadership: All International Business teamsOur Company:We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately...

Position Title: Chief Exports Officer (International Business)Job Description: Chief Exports OfficerLocation: Chandigarh/Panchkula | IndiaReports To: International Business LeadershipTeam Leadership: All International Business teamsOur Company:We are a distinguished, mid-sized Indian pharmaceutical leader, financially robust with revenues of approximately...