regulatory affairs pharmacist
2 weeks ago
Job Description
- Responsible for managing all matters concerning the FDA regulatory requirements specially for Drug Products
- Knowledge and experience with Philippines FDA procedures, regulations and procedure
- Facilitate and monitor submissions of product registration and other related regulatory correspondences with the FDA.
- Develop maintain and monitor a schedule of periodic updates for all regulatory submissions, follow ups etc.
- Proficiency in creating/reviewing packaging layouts in line with existing standards set by FDA
- Responsible for having follow-ups for the applications that the FDA did not yet evaluate for timely release of approval from the FDA.
- Must have QPIRA for Drug &must be aware with ACTD guideline fo FDA Philippines
JOB QUALIFICATIONS:
- Bachelor's Degree in Pharmacy with PRC License
- At least 2 - 4 years of working experience in the related field is required for this position
- Knowledgeable with Food and Drug Administration (FDA) regulatory compliances
- Good interpersonal and communication skills
- Keen to details
- Strong decision-making and leadership capability.
- Team player.
- CAN START ASAP
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