Regulatory Sciences Manager: Strategy & Submissions

Biopharma Careers; Philippines; Hybrid; PHP 1,500,000 - 2,300,000; Full time

Job summary

Pfizer seeks an experienced Regulatory Affairs professional in the Philippines to lead regulatory strategy and coordinate cross-functional teams across local business and R&D initiatives. You will represent Regulatory in cross-functional product teams and guide submissions with NRAs for national registrations and MA variations.

Responsibilities include managing NRA queries, MA renewals, and maintenance of regulatory databases.

Qualifications

• Licensed Pharmacist in the Philippines.
• Experience with national regulatory requirements and regulatory policy.
• Proven ability to deliver regulatory submissions on time, cost and quality.

Responsibilities

• Develop and deliver regulatory strategies to support local business and R&D goals.
• Represent Regulatory on cross-functional teams and provide input to commercial planning.
• Advise on NRA engagements and submission strategy with above-country hubs.
• Respond to NRA queries and manage MA renewal/variation applications.
• Maintain regulatory databases and ensure compliance with SOPs.
• Build relationships with Regulatory Authorities and trade associations.
• Lead development of operating procedures and drive regulatory group development.
• Identify training needs and develop competency within the regulatory team.

Skills

Regulatory strategy

Cross-functional teamwork

Regulatory submissions

Regulatory knowledge

Project management

Communication skills

Stakeholder management

Education

Bachelor of Science in Pharmacy

MBA or MS (advantage)

Job description

Pfizer seeks an experienced Regulatory Affairs professional in the Philippines to lead regulatory strategy and coordinate cross-functional teams across local business and R&D initiatives. You will represent Regulatory in cross-functional product teams and guide submissions with NRAs for national registrations and MA variations.

Responsibilities include managing NRA queries, MA renewals, and maintenance of regulatory databases.