Should be familiar with all aspects of the Products registration/renewal for Generic Pharma/ food supplements/ Nutraceuticals /Cosmetic and medical devices.
Capability to work with regulatory agencies / as well as suppliers/principals regulatory departments and willingness to travel outside the country.
Proficiency in compiling regulatory submission dossiers according to local Philippines FDA regulations.
Proficiency in handling labeling requirements.
Proficiency in creating/reviewing packaging layouts in line with existing standards set by FDA
Should know the regulatory guidelines to be followed prior to and upon the importation of highly regulated Products
Builds and maintains good relations with internal and external stakeholders.
Support Regulatory Affairs team for all GXP-related issues including audits.
Know and understand relevant regulatory rules, guidelines, and procedures within relevant therapeutic areas and devices.
Perform activities for getting new registrations and maintaining registrations as per business goals.
Qualifications:
Bachelor's degree in a relevant field (Pharmacy, Life Sciences, or related discipline).
Excellent written and verbal communication skills.
Ability to manage multiple priorities and meet deadlines.
Attention to detail and strong analytical skills.
Benefits:
Competitive salary and benefits package.
Opportunity for professional growth and development.
