Sr. Manager / AGM - RA (Europe Market)

1. ResponsibleRole & responsibilities

1 Responsible for planning and reviewing new registration and re-registration dossiers for the US/EU countries.

2. Evaluation of queries received from various regulatory authorities and timely response preparation for country submission.

3. Responsible for life cycle management and post-approval activities (variations) for the countries allocated.

4. Coordination with various departments for the arrangement of documents and their review for dossier preparation.

5. Due diligence of documents and registration dossiers before the country submissions.

6. Communication and Coordination with Country Partners and IB for timely MOH submission

7 Guiding to F&D/ADL on regulatory intelligence and review of developmental documents

8. Responsible for updating and managing regulatory-related software.

9. Artwork review and its management.

10 eCTD software operations

Preferred candidate profile

Must be good in communication & presentation skills.

Good in team handling skills.

Perks and benefits