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Regulatory Affairs Specialist
2 weeks ago
Pharmaceuticals & Medical Devices (Healthcare & Medical)
Full time
Add expected salary to your profile for insights
Job Description - Regulatory Affairs PharmacistWe are looking for an experienced Regulatory Affairs specialist with in-depth knowledge of ASEAN Regulatory requirements in the Registration of pharmaceuticals, medical devices, food supplements marketing authorization and licenses. Knowledge in implementation of pharmaco-vigilance will be an advantage. Quality experience in interacting with Center for Drug Regulation and Research (CDRR), Center for Food Regulation and Research (CFRR) etc
- You will be in-charge of all regulatory issues and affairs related to the company and different regulatory bodies with respect to the products assigned under your responsibility.
- Communicate and coordinate with all manufacturing partners/suppliers with based on local FDA guidelines on product registrations or other pertinent issues as applicable.
- Coordinate and communicate with the concerned quality control and/or regulatory officers of manufacturing partners/suppliers to ensure adherence to mutually acceptable quality standards for the product as required to be complied by FDA Philippines
- Knowledge and skill in review of Product's Technical Dossiers (CTD) and other pertinent documents and issues related to product registration with FDA Philippines.
- Proficiency in research and analysis for information and issues related to product specific knowledge if necessary is expected.
- Create and maintain proactively an updated database of all product registrations and licenses as necessary for renewals and submit the necessary requirements ahead of time.
- Act as the authorized pharmacovigilance officer for the company by actively coordinating the issues of product complaints/quality with the end-user and or regulatory authorities, maintain updated log for submitted product complaints etc.
- Represent the company in various FDA sponsored activities, public hearings and seminars as necessary.
What's your expected monthly basic salary?
Retail & Consumer Products
Philcare Pharma, Inc. is a fast and aggressively growth oriented Filipino pharmaceutical company focussed in creating its unique space in the niche area of IV Anesthesia and Critical Care. In a very short-span of 4 years, the company has been able to make its presence felt in the medical community via its fresh and diffeernt approach to growing its business. The company has witnessed a stellar growth at a compounded average growth rate of 90% plus every year since 2013 and it is aspiring to grow at an average growth rate of 50% for the next 5 years
Philcare Pharma, Inc. is a fast and aggressively growth oriented Filipino pharmaceutical company focussed in creating its unique space in the niche area of IV Anesthesia and Critical Care. In a very short-span of 4 years, the company has been able to make its presence felt in the medical community via its fresh and diffeernt approach to growing its business. The company has witnessed a stellar growth at a compounded average growth rate of 90% plus every year since 2013 and it is aspiring to grow at an average growth rate of 50% for the next 5 years
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