Regulatory AssistantOrganique Inc.

Description
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 company
- Assists 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 advantage
- Candidate must be a duly licensed pharmacist with the PRC and in good standing.
- Full-Time position(s) available.
Requirements
Minimum education level: Bachelor ́s Degree
Years of experience: 5
Knowledge: Communication and persuasion, Real State, Performance optimisation
Availability for travel: Yes
Availability for change of residence: Yes

Makati, National Capital Region ·  30 September (updated)
Work type
Full Time