Responsible for compilation & submission of Dossier of a generic drug.
Hand on experience in Filing dossiers to regulated, emerging and ROW markets.
Experienced in CTD/ACTD and Regional Module.
Experience in Filing in EU, ASEAN, MIDDLE EAST AND LATAM regions.
To obtain approvals for relevant product marketing, Registration Certificates and export permission.
Key Responsibilities:
1) The Responsible for task involving evaluating dossiers/queries and compilation of critical dossiers and queries, as and when required. This includes search/retrieval/editing of data logically for preparation of dossier/query.
2) Will be responsible for maintaining high moral/discipline and secrecy of the
Regulatory Affairs Department with effective correspondence / liaison with manufacturing plants for timely procuring the required data for dossier preparation.
3) Experience with Injectable is a must. A combination of medical devices and pharma will be a plus.
Desired candidate profile:
1) Minimum 4-8 years of experience in Pharmaceutical Regulatory Affairs
2) Worked with Pharmaceutical Formulation Regulatory department
3) Hands on experience to manage formulation regulatory
Job Type: Full-time
Pay: ₹30,000.00 - ₹70,000.00 per month
Work Location: In person
Beware of fraud agents! do not pay money to get a job
MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.