Regulatory Officer

Job Duties and Responsibilities

- Represents the company to regulatory authorities and will be designated as company Pharmacist in the licenses to operate

• Prepares and safe keep documents for submission to regulatory authorities

• Keeps track of submissions and approvals as per agreed filing plans

• Maintains product registrations, licenses, artworks and labels in compliance with local regulations, corporate policies, standard operating procedures (SOP) and systems

• Performs regulatory-assigned activities and roles in support of business objectives

Collaborates with stakeholders in the development and implementation of strategies to meet regulatory submissions and approvals, mitigate supply risks and address compliance issues

• Contributes to change management and continuous improvement projects

• Initiate and develop complex regulatory requirements

• Identifies and prioritizes key areas of regulatory risk

• Maintains data base and hard copies of all product regulatory documents

• Heads the safety programs as the Company Health's Officer

• Performs other assignments that may be deemed necessary by the Chief Executive Officer.

Qualifications:

• Graduate of Bachelor of Science in Pharmacy, Chemistry, Biology, Microbiology, Food Technology / Food Science, and any related field

• Must be a registered Pharmacist in the Philippines

• At least 1 year of working experience in the field of regulatory affairs

• Good knowledge of regulatory guidelines and various areas

• Ability to effectively and consistently deliver on time and as per quality standards, in a complex matrix environment

• Good written and spoken communication skills

• Accurate and keen to details

• Proficient in the use of digital tools/systems