Vacancy for Manager Regulatory Affiars at Ananta Medicare Limited

Anantha Medicare Limited - Pharmawalks

We hiring for Manager in Regulatory Affiars department for Anantha Medicare Ltd.

Department: Regulatory Affiars
Position: Manager
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: hr@anantamedicare.in

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