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Regulatory Affairs Pharmacist

2 months ago

Metro Manila, Philippines SUN PHARMA PHILIPPINES, INC. Full time

SUN PHARMA PHILIPPINES, INC. is a subsidiary company of Sun Pharmaceutical Industries Ltd. 

 

SUN PHARMA is the 1st largest pharmaceutical company in India and the world 4th largest specialty generics pharmaceutical company committed in providing international standards of quality. With 43 state-of-the-art manufacturing facilities spanning 5 continents located in US, Japan, Canada, Hungary, Israel, Bangladesh, South Africa, Malaysia, Romania, Egypt, Nigeria. We have a strong ground network of over 37,000 committed employees representing over 50 nationalities with a pipeline of over 2,000 best-in-class products to patients across more than 100 countries worldwide.

 

JOB RESPONSIBILITIES

Preparation and submission of initial/renewal registrations and variation documents of drug products in FDA.Evaluates and assists in the collation of regulatory documents for FDA submission (initial/renewal registration documents of drug products including variations.Coordination with Corporate Regulatory Affairs in head office via email and telecon if requires.Provides updates to head office regarding new laws on product regulation and registration development.Secures and update FDA license of the companyAssists FDA inspections in the office.Assists in monitoring trademark approvals.Assists in the preparation and submission of trademarks applications in IPO.Reviews and provides assistance for development of packaging materials.Assists in the preparation of requirements for product inclusion in the hospitals.Assists in the preparation of requirements for bidding.Assists in the preparation of requirements for company accreditation.

 

QUALIFICATIONS

Candidate must possess at least a Bachelor's/College Degree , Professional License (Passed Board/Bar/Professional License Exam), Pharmacy/Pharmacology or equivalent.Minimum of 5 years of working experience in the related field is required for this position.Knowledge in ACTD, Bioequivalence and Biowaiver is an advantageCandidate must be a duly licensed pharmacist with the PRC and in good standing.Full-Time position(s) available.Must be willing to work in BGC