Randstad
Location
Goa | India
Job description
- Leading regulatory compliance team.
- Preparing the strategy for regulatory filing within time frame.
- Compilation, review, and submission of dossier for drugs product registration in US and Europe
markets.
- Submission of response of queries received from Country’s Regulatory Agents and Regulatory
Agencies.
- Review of plant documents like batch records, process validation protocols and reports etc.
- Review the documents prepared by R&D like PDR, analytical method validation/verification
protocols and reports, MMF etc.
- Assist the formulation development and analytical development team during development of
product.
- Review of API DMF and coordination for the documents.
- Preparation and review of labelling documents like SPC and PI.
- Co-ordinate in preparing the artwork and approval of the labelling text.
- Compilation and submission of post approval supplements, annual report and PADER for US
market
- Compilation and submission of variation for Europe and ROW markets.
- Provide the regulatory inputs during development of drug product.
- Coordinate with Regulatory Agencies.
- Publishing the dossier/variations/post approval supplements/annual report in eCTD manager.
- Life cycle management of drug products and support to the plant for commercial supply.
- Coordinate with different clients and affiliates to timely submission of dossier/response.
- Coordinate with different departments (QA, QC, Production and R&D) for availability of
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