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**Division**:
- IPD**Department**:
- IPD**Employment Type**:
- Permanent**Job Purpose**:
Execute the regulatory assurance and training processes by maintaining RA documentation systems, tracking regulatory commitments and annual report submissions to achieve regulatory assurance for Cipla
**Accountabilities**:
I. Check the regulatory commitments from Registration, Variations and Renewals till closure by continuous tracking and following defined procedures to achieve compliance to regulatory filings.
II. Check timely submission of Annual Report for all formulations and API registered with US market through defined procedures to meet compliance with US regulatory requirement.
III. Gather the impact of Import Alerts to registered API manufacturers and collate the impact assessment to ensure timely submission to CQA.
IV. Check timely submission of Biannual Report to Canada & annual report for South Korea DMF and WHO APIMF to meet compliance with regulatory requirement.
**Education Qualification**:
B Sc./ MSc / B. Pharm / M. Pharm
**Relevant Work Experience**:
3-5 Years of experience in quality or regulatory
**Competencies/Skills**:
- Communication Skills (clarity of thought, comprehension)- Likely potential for growth- Job / Product / Technical Knowledge / Pharma domain knowledge- Presentation & Interpersonal skills (If applicable)- Managerial or People Management skills- Safety awareness (If applicable)- Relevance of Previous Experience- Comprehension, Analytical & Problem solving abilities- Productivity & Result Orientation (If applicable)- Attitude- Qualification fitment- Sales drive (If applicable)- Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)**Job Location**:
Vikhroli
**Shift Hours**:
