Javed Alam
Manager |Medical & Scientific Writer| Medical Regulatory Affairs| WHO-HTA-Fellow|
- Role
- Manager Global Regulatory Affairs at Amgen
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Javed Alam
Completed B Pharm from Lloyd Institute, Noida and M Pharm (Pharmacology) from Poona College of Pharmacy, Bharati Vidyapeeth University, Pune in Aug 2014. Initiated a professional from Kinapse > Siro Clinpharm > Cognizant > CitiusTech Healthcare. Currently, working as Global Regulatory Manager.Specialties: An eye for quality.
Experience
Manager Global Regulatory Affairs
Apr 2025 — Present
Education
Motivational Pathway
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
Jawahar Navodaya Vidyalaya, Bijnor
All India Senior School Certificate Examination, 2006, Biology, General
1998 — 2006
Bharati Vidyapeeth Deemed University
Master of Pharmacy (M. Pharm) , Pharmacology
2012 — 2014
Skills
- Regulatory Submissions
- Life Sciences
- Clinical Development
- Pharmaceutics
- Drug Discovery
- Fdaaa Final Rule 2016
- Pharmacology
- Regulatory Affairs
- Lifesciences
- Pharmaceutical Research
- Fdaaa
- Quality Assurance
- Validation
- Hplc
- Formulation
- Pharmacokinetics
- Oncology
- Protocol
- Medical Writing
- Research
- Biotechnology
- CRO Management
- Clinical Research
- Clinicaltrials.gov
- Regulatory Requirements
- CRO
- Ich-Gcp
- Toxicology
- Eudract
- Standard Operating Procedure (Sop)
- Clinicaltrials.gov Protocol Registration and Results System (Prs)
- Pharmaceutical Industry
- Sop
- Clinical Trials
- Pharmacm
- Pharmacovigilance
- High-Performance Liquid Chromatography (Hplc)
- Gmp
- In Vitro
- Glp
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