Executive Officer Drug Regulatory Affairs

Job Title Drug and Excise Regulatory Affairs Executive Company Dr Lorman s Homeopathic Associates Pvt Ltd Location Panchkula Haryana Reports To Regulatory Affairs Manager Senior Management Job Summary Dr Lorman s Homeopathic Associates Pvt Ltd is seeking a dedicated Drug and Excise Regulatory Affairs Executive to manage regulatory...

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...

**Job description** 1.Prepare and submit regulatory documents with Food and Drug Administration for product approvals and renewals 2. Maintain up-to-date knowledge of regulatory requirements, guidelines, and industry trends. 3. Maintaining BMR and BPR records 4. Checking and approving Products artwork 5. Support regulatory inspections and audits,...

Role & responsibilitiesRegulatory Strategy Development:Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc.Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these...

Role & responsibilities Regulatory Strategy Development: Develop and implement regulatory strategies for the registration and market access of pharmaceutical products, particularly injectables, in ROW regions including Africa, CIS, LATAM, etc. Monitor and assess regulatory trends, changes in legislation, and health authority requirements in these regions....

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

**Key Responsibilities**: Prepare and compile documents for FDA approval, COA, MSDS and other regulatory submissions in line with updated industry standards and guidelines. Prepare, update, and maintain Batch Processing Reports (BPRs) as per regulatory and internal quality protocols. Verify product labels, packaging, and design for conformity with Legal...

Role & responsibilities Regulatory 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...

Our client is in search of a Government Affairs Manager for a MedTech company onsite in Gurgaon, India. *Candidate "must have" Medical device or pharma or IVD experience, will not be chosen otherwise. The Role The Government Affairs Manager will be responsible for public policy engagement, government KOL advocacy, and initiating project-based...

Chief Export Officer - International BusinessThe Chief Exports Officer (CXO) will be entrusted with the strategic and operational command of Venus international commercial business with a primary focus on driving tangible sales and PL ownership. This pivotal role is central to achieving our ambitious global growth targets, not just by identifying...