We hiring for Manager in Regulatory Affiars department for Anantha Medicare Ltd.
Department: Regulatory Affiars
Eligibility: B. Pharm / M. Pharm / Relevant Graduates with 3+ years experience in the drug regulatory affairs functions for the export of finished formulations to the EU / US markets.
Roles and Responsibilities:
- Co-ordination with the manufacturing plants and other departments for preparation of dossiers and regulatory documents.
- Preparation of pharmaceutical (all forms) of registration dossiers and variations/ amendments/ annual reports as applicable documents in CTD and eCTD format according to EU regulatory requirements.
- Review and approve change controls/ deviations/ OOS and relevant site related documents.
- Monitor changes in guidelines including pharmacopeia changes, evaluate the impact of changes on ongoing-marketed products, and communicate proactively to QA/QC and operations at plants, including contact persons for third parties for third party related products.
- To write and check/review of documents as per regulatory requirements.
- To response to regulatory deficiencies letters according to EU and USA regulatory requirements.
- To maintain lists/documents/records.
Desired Candidate Profile:
- B. Pharm / M. Pharm / Relevant Graduates with 3+ years experience in the drug regulatory affairs functions for the export of finished formulations to the EU / US markets.
- Should be well versed with Regulatory Guidelines. Knowledge of Preparation, compilation & review of CTD, ACTD & ECTD Dossiers.
- Should be well versed in Handling customers & MOH query with respect to technical documentation (Stability Data, GMP, FSC, DMF etc.).
- Fluency in oral and written English.
Interested candidates Please send your resumes to: email@example.com