Subhash Dhende
Associate Regulatory Affairs
- Role
- Regulatory Affairs Associate at Cipla
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Subhash Dhende
Global Regulatory StrategiesRegulatory Submissions & MeetingsDossier writing: registering the products in ROW markets for Africa region in CTD format as per country specific guidelines.Response to Health Authority.Regulatory Maintenance of Older ProductsLabeling Updates and Harmonization of Labels
Experience
Regulatory Affairs Associate
Jul 2016 — Present · Mumbai, IN
Handling life cycle management of the product (change controls, variations, re-registrations and deficiencies on variations/ re-registrations) Assessing applicability and impact of change controls. Compilation of post approval submissions for Row and Europe Market. Compilation of re-registration dossiers. Product evaluations for renewal of dossiers. Co-ordinating with other departments (e.g. QA, IPD, manufacturing) to get the relevant documents for all types of life cycle management.
Education
University of Pune
Bachelor’s Degree
2009 — 2013
University of Mumbai
Master’s Degree
2013 — 2015
Skills
- Performance Management
- Regulatory Submissions
- Leadership
- Corrective and Preventive Action (Capa)
- Teamwork
- Team Management
- Glp
- Microsoft Word
- Soft Skills
- Pharmaceutics
- Hplc
- Analysis
- Microsoft Office
- Regulatory Affairs
- Quality Assurance
- R&D
- Management
- Life Sciences
- Dissolution
- Validation
- Microsoft Excel
- Powerpoint
- Pharmaceutical Industry
- Sop
- Customer Service
- Uv
- Biotechnology
- Dossier Preparation
- Research
- Capa
- Analytical Methods Development
- Employee Relations
- Training
- High-Performance Liquid Chromatography (Hplc)
- Gmp
- M.pharm QA
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