Senior Regulatory Strategy & Submissions Lead

Pfizer; Philippines; Hybrid; PHP 1,200,000 - 1,800,000; Full time

Job summary

Pfizer is seeking an experienced Regulatory Affairs professional in the Philippines to lead regulatory strategies for local and development products. You will represent Regulatory on cross-functional teams, advise on compliance and national requirements, and coordinate submissions with national authorities.

You will manage NRAs, renewals, variations, and unlicensed supply approvals, while developing external relationships and ensuring regulatory databases are up to date.

Qualifications

• Graduate of Bachelor of Science in Pharmacy or equivalent.
• Registered Pharmacist in the Philippines.
• Minimum of 6 years solid working experience in regulatory sciences.
• Fluent in English – written and spoken communication skills.
• Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
• Regional regulatory experience including knowledge of CTA's and NDA submission processes and product life cycle management activities.

Responsibilities

• Develop and deliver optimal regulatory strategies to support local business and R&D goals for licensed and development products.
• Represent Regulatory on cross-functional product teams and provide strategic regulatory input to commercial planning.
• Coordinate pre-submission meetings and NRA engagements for national registrations.
• Input to filing strategy and provide country documentation for dossier build.
• Respond to NRA queries in partnership with above-country hubs and strategists.
• Develop and maintain relationships with Regulatory Authorities and trade associations to negotiate favorable outcomes.
• Maintain regulatory databases and document management for regulatory transactions.
• Support MA divestments, cancellations, discontinuations and supply continuity.
• Lead development of procedures and ensure GRP compliance and inspection readiness.

Skills

Regulatory affairs

Pharma regulatory knowledge

English proficiency

Leadership

Project management

Education

Bachelor of Science in Pharmacy

Registered Pharmacist in the Philippines

MBA or MS (advantage)

Job description

Pfizer is seeking an experienced Regulatory Affairs professional in the Philippines to lead regulatory strategies for local and development products. You will represent Regulatory on cross-functional teams, advise on compliance and national requirements, and coordinate submissions with national authorities.

You will manage NRAs, renewals, variations, and unlicensed supply approvals, while developing external relationships and ensuring regulatory databases are up to date.