Regulatory Affairs Manager – Vaccines & Biologics, Growth Opportunities

Zuellig Pharma; Parañaque; On-site; PHP 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Inclusive environment

Diversity, equity & inclusion

Growth opportunities

Total Rewards program

Job summary

Zuellig Pharma is seeking an experienced Regulatory Affairs Manager to lead regulatory activities for biologicals, vaccines, and healthcare products in the Asia region. You will drive registration strategies, ensure lifecycle compliance, and liaise with authorities to enable market access.

The role requires 3–5 years of managerial Regulatory Affairs experience, strong regulatory knowledge, and proficiency in coordinating cross-functional teams and external regulators.

Qualifications

• Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• 3–5 years of managerial experience in Regulatory Affairs.
• Strong knowledge of pharmaceutical regulatory requirements, product registration, and lifecycle management.
• Experience engaging with regulatory authorities and managing stakeholder relationships.

Responsibilities

• Evaluate and prepare dossiers and technical documents for new product registrations and submissions for biologicals, vaccines, and healthcare products.
• Ensure regulatory compliance of assigned products throughout the product lifecycle and support commercialization initiatives.
• Develop and implement regulatory strategies, identifying risks and opportunities that may impact product approvals and market access.
• Collaborate with partners, cross-functional teams, and regional stakeholders to communicate regulatory updates and drive regulatory objectives.
• Represent the company before regulatory health authorities, including FDA and other government agencies, on regulatory matters.
• Review and approve product labeling, packaging artworks, promotional materials, and Veeva submissions to ensure regulatory compliance.
• Monitor new and existing regulations, provide regulatory intelligence, and cascade regulatory updates to relevant stakeholders.
• Maintain regulatory databases, trackers, reports, and documentation to support compliance and business requirements.
• Support the Regulatory Affairs Director in strategy development, regulatory training, SOP creation, and process improvement initiatives.
• Represent the organization in industry associations and advocate for key regulatory and healthcare initiatives

Skills

Regulatory affairs

Stakeholder management

Project management

Cross-functional colla

Education

Bachelor's Degree in Pharmacy

Job description

Zuellig Pharma is seeking an experienced Regulatory Affairs Manager to lead regulatory activities for biologicals, vaccines, and healthcare products in the Asia region. You will drive registration strategies, ensure lifecycle compliance, and liaise with authorities to enable market access.

The role requires 3–5 years of managerial Regulatory Affairs experience, strong regulatory knowledge, and proficiency in coordinating cross-functional teams and external regulators.