Pfizer Regulatory Affairs Specialist (CTA Support) in Makati City, Philippines
The Regulatory Affairs Executive (CTA) is mainly responsible for regulatory affairs support related to developmental, new and in-line products within the country, with a special focus on Clinical Trial Application. The activities encompass CTA/regulatory submissions to the authorities for IND and new products and supporting related activities such as query response and general product maintenance.
The role will support activities in Philippines market primarily, with a potential expansion of support to other ASEAN countries.
Let's bring this details to the top of Primary responsibilities:
Clinical Trial Support: Primarily for Philippines (with potential expansion of support to other ASEAN Countries)
Ensures quality filings of IND submission and approval
Liase with the CTA Hub to plan submission strategies
Provide in-consult support on CTA requirements to internal stakeholders
Be the contact point for with HA on matters related to CTA submissions
Qualifications (i.e., preferred education, experience, attributes)
1 year of working experience (handling Clinical Trial Application (CTA) and/or working in Regulatory Affairs function )
Fluent in English - written and spoken communication skills
Good knowledge of international and local regulatory/CTA guidelines and codes
Preferably with knowledge across multiple therapeutic areas
Meticulous nature and proficient in data tracking and consolidation
Proven ability to consistently deliver to time, cost and quality standards.
Ability to effectively deliver in
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.