Suvi Neelam Email & Phone Number

Auckland, New Zealand

Auckland, New Zealand

• Decontamination of materials• Printing labels and batch documents• Compounding/mixing product in the cleanroom• Checking, packing, and labelling final product• Ensuring completion of documentation• An eye for detail and meticulous record-keeping skills

Mumbai, Maharashtra, India

I feel great pleasure making myself Freelancer and providing my services to individuals, institutions and organizations with respect to Regulatory affairs.I have been involved with all aspects of regulatory affairs activities from Dossier compilation to all regulatory activities involved in the life cycle management of pharmaceutical medicinal products. I have experience of Dossier compilation for Regulated and Semi regulated markets (CTD / ACTD) in-line with Country-specific guidelines. Ensure timely compilation and submissions of CTD Modules / Country specific formats

Mumbai Area, India

• Preparation, Review & compilation of dossiers for submission to regulatory body.• Preparation of dossiers in CTD, ACTD format & countries specific format as per the current guidelines for the Asia pacific & African countries. • Preparation of legal documents required for registration as per countries requirement, for example. CPP, FSC. GMP, ML, POA SLSPP certificate, etc.• Update & submit all products information’s (SmPCs, PIL’s & artworks for package labelling).• Timely processing and compilation of regulatory information in accordance with requirements & regulations in ROW market to ensure high quality regulatory submissions. • Synchronize with various departments (production, quality control, and quality assurance, R & D, F&D) to collect required input for timely regulatory submission of products.• Contributing to preparation of SOP’s & working instructions to define the work processes within regulatory team.• Evaluation and Timely Submission of Variation applications.• Co-ordination in query response after regulatory submission.• Preparation & Maintenance of Payments Request Form (PRF) for timely payment of Registration & also providing support in budgeting in Regulatory expenses.• Preparation of Fische Techniques for Tender submission.• Conducted Verification Audits of Suppliers to assess and ensure good quality documentation.

Mumbai Area, India

- Vendor qualification & evaluation – R/M & P/M- To review and approve the Vendor questionnaire documents.- To provide the technical data of Vendor Qualification during Plant audit.- Co-ordination with other Departments like Production, QC, purchase dept. and regulatory affairs dept., AMD &PDR dept.- To monitor the routine Enterprise Resources Planning (ERP) activities.- Resolve plant queries in ERP related to purchase order.- Preparation & Review of Specification, Standard Test Procedures & Data Sheet (SPEC / STP / DS) of Raw material, Packing Material & finished product.- Coordination with RA and fulfilling their requirements with respect to filing new drug products and annual update.

Post Graduation In Regulatory Affairs

Bachelor Of Pharmacy - Bpharm