November 26, 2020 by admin
Status: Regular Full Time
The Regulatory Pharmacist will act as a link between the company and regulatory authorities, ensuring that products are distributed in compliance with appropriate legislation.
Roles and Responsibilities:
– Responsible for managing all matters concerning the Regulatory Department pertaining to Drugs, Medical Devices, Food, Cosmetics.
Knowledge and experience with Philippines FDA procedures, regulations and procedure.
– Monitor and check submissions of License to Operate, CPRs and other related regulatory correspondence with FDA.
– Develop and maintain a schedule of periodic updates for all regulatory submissions, follow ups etc.
– Ensure that all FDA licenses, certificates and permits are updated and valid.
– Proficiency in creating/reviewing packaging layouts in line with existing standards set by FDA.
– Update related departments on latest regulatory requirements.
– Perform other related duties as required by FDA, other Government Agencies and other tasks assigned as needed.
– Organize and maintain the regulatory filing system.
– Bachelor’s Degree in Pharmacy/Pharmacology with valid PRC License.
– 3 to 5 years of working experience in the related field is required for this position.
– Knowledgeable with Food and Drug Administration (FDA) regulatory compliances.
– Excellent level in verbal and written communication skills.
– Knowledge in Graphic Designing will be an advantage.
– Organized and attentive to details.
– Demonstrate pro-active approaches to problem-solving with strong decision-making capability.
– Good interpersonal skills.
– Computer proficient and capable in Microsoft Office, Google Suite, etc.