Regulatory Affairs specialistPfizer

Job Summary
The Regulatory Affairs Specialist provides support in the development and implementation of regulatory strategies on the registration and lifecycle management of assigned products to meet business objectives and ensure compliance with local regulations.
Job Responsibilities
Represents the company to regulatory authorities and may be designated as Company Pharmacist in one of the licenses to operate of the company.
Prepares 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 (SOPs) and systems.
Performs regulatory-assigned activities and roles in support of business objectives.
Collaborates with in-country and above-country 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.
Qualifications
Graduate of Bachelor of Science in Pharmacy or equivalent
Registered Pharmacist in the Philippines
Preferably with 1 year of working experience in the field of regulatory affairs
Good written and spoken communication skills
Good knowledge of regulatory guidelines and various therapeutic areas
Meticulous and keen to details
Proficient in the use of digital tools/systems
Ability to effectively and consistently deliver on time and as per quality standards, in a complex matrix environment
#LI-P
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
#LI-PFE
Pfizer

Makati City, Metro Manila
Permanent
Full-time