Regulatory Affairs Manager – Biologics & Vaccines

Zuellig Pharma

Cebu City

Presencial

PHP 1.200.000 - 1.800.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Zuellig Pharma is recruiting a Regulatory Affairs Manager for its Sun Valley, Philippines operation. You will lead regulatory activities to ensure timely product registrations, lifecycle maintenance, and compliance for biologicals, vaccines, and healthcare products.

You will develop strategies to support market access and liaise with authorities and internal teams. The role requires a Pharmacy degree with licensure and 3–5 years of managerial regulatory experience, plus strong regulatory

Formación

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

Responsabilidades

  • Prepare dossiers and submissions for biologicals, vaccines, and healthcare products.
  • Ensure regulatory compliance across product lifecycle and support commercialization.
  • Develop regulatory strategies and assess risks to approvals and market access.
  • Collaborate with cross-functional teams and regional stakeholders.
  • Represent the company before health authorities on regulatory matters.
  • Review labeling, artworks, promotional materials, and Veeva submissions.
  • Monitor regulations and provide regulatory intelligence to stakeholders.
  • Maintain regulatory databases, trackers, and documentation.
  • Support Regulatory Affairs Director with SOPs and process improvements.
  • Represent the organization in industry associations and advocacy initiatives.

Conocimientos

Regulatory leadership
Stakeholder management
Project management
Team leadership

Educación

Bachelor's degree in Pharmacy

Herramientas

Veeva

Descripción del empleo

Zuellig Pharma is recruiting a Regulatory Affairs Manager for its Sun Valley, Philippines operation. You will lead regulatory activities to ensure timely product registrations, lifecycle maintenance, and compliance for biologicals, vaccines, and healthcare products.

You will develop strategies to support market access and liaise with authorities and internal teams. The role requires a Pharmacy degree with licensure and 3–5 years of managerial regulatory experience, plus strong regulatory

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