Executive Dra

**This includes but not limited to**:

- Compilation of Regulatory and Non Regulatory Documents / Dossiers in Regulatory Affairs.
- Compilation of Regulatory Documents (USDMFs) in CTD & eCTD format.
- Compilation of Annual reports, Amendments, Query response on Chemistry manufacturing and control to USDMFs.
- Good Hands of experience in preparation of DMF & CEP in eCTD format.
- Good domain knowledge over dossier filing and handling of related deficiency for regulatory and Semi regulatory market.
- Good work exposure in regulatory USFDA, EUGMP (German health Authority) approved plant.
- Submissions of EDMFs / Dossiers to Different EU Regulatory Authorities with support of MAA.
- Compilation of CEPs (Dossier) to the European Directorate for the Quality of Medicines(EDQM).
- Compilation of CEP Revisions/Renewals.
- Good experience for submission of dossier for Decentralized procedure or National procedure in EU countries.
- Review of Raw materials, Starting materials, intermediates & API Specifications and MOAs, Process validation documents etc.
- Timely Submission of query responses to Regulatory Authorities.
- Preparation and maintenance of Life cycle management of ASMF and DMF, updation of changes to approved CEP, USDMF.
- Timely submitting the Applicant DMF and response to customers.
- Coordinate with crossfunctional teams for documentation required for DMF submission.
- Maintain Access Database on products submitted with Various Authorities/ Applicant.
- Graduate / Post Graduate in Chemistry with minimum 5-6 Yrs of experience in Regulatory Affairs in API / Bulk drugs
- Good Interpersonal and communication skills, committed
- Result oriented, hardworking with quest and zeal to learn new technologies and undertake the challenging tasks

**Job Type**: Regular / Permanent

**Salary**: ₹600,000.00 - ₹700,000.00 per year

**Benefits**:

- Health insurance

Schedule:

- Day shift

Supplemental pay types:

- Overtime pay
- Performance bonus
- Yearly bonus

**Experience**:

- total work: 3 years (preferred)