Sowmya Dinesh
Associate Director
- Role
- Associate Director - Regulatory Affairs at ClinChoice
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Sowmya Dinesh
Strategic focus Communication & Negotiation skills. Project management Skills. Excellent verbal, written, presentation and organization skills. Excellent interpersonal skills Multi-tasking Attention to detail & quality. Leadership and resource management. Problem solving & crisis management.
Experience
Associate Director - Regulatory Affairs
Jan 2022 — Present · Bengaluru, IN
Qualitative assessment of registration documents, Gap analysis of age-old registered dossier with current regulatory requirement for registration into new market or market expansion. Active role in strategic decisions and implementation Develop sustaining relationships with internal and external customers to effectively communicate appropriate regulatory requirements and opportunities. Working & handling multiple projects for different stakeholders & clients. Post approval submissions involving, Quality changes, safety changes, CCDS updates, administrative changes, Labelling changes etc Markets handled - EU market Project management along with handling different team working on drug product, cosmetics, medical devices life cycle management project. Active participation in responding to RFI’s and RFP’s
Education
Christ University, Bangalore
Bachelor of Science (BSc), Physics, Chemistry and Maths
2001 — 2004
Bangalore University
M.Sc, Organic chemistry
2004 — 2006
Skills
- Regulatory Affairs
- V&V
- Technology Transfer
- Gmp
- Dissolution
- Regulatory Requirements
- Anda
- Cleaning Validation
- Regulatory Submissions
- Mhra
- Ectd
- Pharmaceutical Industry
- Sop
- Glp
- Generic Programming
- Analytical Method Validation
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