Regulatory affairs Officer / Executive Vacancies Gurgaon
urgent vacancy for Regulatory Affiairs in our company @ Coral Drugs Pvt. Ltd-API (Gurgaon/ Sonipat).
Job Description: –
Regulatory affairs jobs – Coral drugs
Designation : Officer / Executive – RA
- Preparation and compilation of DMF for US, EU, CEP, Canada, Japan, China, Brazil and other semi-regulated markets.
- Submission of technical data package and Applicant’s Part for semi-regulated markets
- Submission of response to deficiencies received from authorities and customers
- Periodic DMF updates (annual report for USDMFs and CEP renewal) and DMF amendments for post approval changes for US, EU, Canada, CEP and other markets
- Use of eCTD software’s and submission gateways like ESG & CESP
- Providing regulatory inputs in early development phase of APIs
- Review of change controls and technical data required for DMF submissions
- Collection and review of data (AMV, process Validation stability etc.) required for compilation DMF
- Preparation of LoA and commitment and data management
- Submission of change notification for customer.
- Tracking of changes in pharmacopoeia, regulatory guidance, current trends / regulatory expectations and identification of gaps
- Maintenance of database for regulatory submissions including customer notifications · Well versed with current regulatory guidelines.
Application Process : Interested can share our CV @ hrcdpl-3@coraldrugs.com