Minoo Biju
Head-Regulatory Affairs at Global Pharma Company|Driving global submissions, approvals and life-cycle management
- Role
- Head-regulatory Affairs at Piramal Pharma Solutions
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Minoo Biju
Experienced Regulatory Affairs having worked on drug product and drug substance submissions to USFDA (ANDA\'s, DMF\'s)* Prior experience of formulation development of drug products (varied dosage forms) for domestic and export markets* Worked in production and packaging of dosage forms (tablets, capsules, liquids, semi-solids and oral powders)* Efficient and effective co-ordination with related departments * Aims to help in filing of applications with reduced lead times for approval from agencies thus helping organization to enter the market faster and more effectively * Provide regulatory insight to various related departments to help minimize changes and work on an optimized product right at the startSpecialties: Regulatory support to stakeholders, technical knowledge, critical review of documents based on good science and regulatory requirements
Experience
Head-regulatory Affairs
Sep 2018 — Present
Education
Bombay college of pharmacy
B Pharm, Pharmacy
1990 — 1994
Skills
- Healthcare
- Regulatory Guidelines
- Formulation
- Quality Auditing
- Generic Drugs
- Medical Devices
- Health Economics
- Capa
- Abbreviated New Drug Application (Anda)
- Anda
- Glp
- Generic Programming
- Standard Operating Procedure (Sop)
- Regulatory Affairs
- Analytical Method Validation
- Ectd
- Pharmaceutics
- Cardiology
- Research and Development (R&D)
- Regulatory Requirements
- Pharmaceutical Industry
- Sop
- Nmr
- Fda
- Validation
- Pharmacovigilance
- U.s. Food and Drug Administration (Fda)
- Gmp
- Regulatory Submissions
- Biochemistry
- R&D
- Regulatory Documentation
- Technology Transfer
- Nda
- Biologics
- Software Documentation
- Edc
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