Gerente de Asuntos Regulatorios

Empresa Confidencial; Philippines; Hybrid; PHP 2,191,000 - 3,287,000; Full time

Benefits offered by this job

International exposure

Cross-functional exposure

Professional growth

Competitive compensation

Job summary

Empresa Confidencial is seeking a Regulatory Affairs Manager to develop and execute regulatory strategies, manage submissions and lifecycle activities, and ensure compliance with local and global regulations. The role requires collaboration across Medical, Quality, Supply Chain, Commercial, and Global Regulatory teams within a multinational setting.

The ideal candidate will have a Bachelor's degree in a related field, at least 3 years of Regulatory Affairs experience, and strong English

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or related field.
• Minimum 3 years of experience in Regulatory Affairs within pharmaceutical industry.
• Experience with regulatory submissions and health authority interactions.
• Strong knowledge of applicable pharmaceutical regulations and compliance requirements.
• Advanced English proficiency.

Responsibilities

• Develop and execute regulatory strategies in alignment with business objectives.
• Lead regulatory submissions, registrations, renewals, variations, and lifecycle management.
• Ensure compliance with local and international regulatory requirements.
• Collaborate with Medical, Quality, Supply Chain, Commercial, and Global Regulatory teams.
• Maintain relationships with health authorities and support inspections.
• Provide regulatory guidance for new products and portfolio activities.
• Monitor regulatory changes and assess impact on the business.

Skills

Regulatory affairs

Regulatory submissions

Health authority interactions

Project management

Stakeholder management

Cross-functional collaboration

English proficiency

Education

Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology

Job description

REGULATORY AFFAIRS MANAGER | PHARMACEUTICAL INDUSTRY

Key Responsibilities

• - Develop and execute regulatory strategies in alignment with business and compliance objectives.
• - Lead regulatory submissions, registrations, renewals, variations, and lifecycle management activities.
• - Ensure compliance with applicable local and international regulatory requirements.
• - Collaborate cross-functionally with Medical, Quality, Supply Chain, Commercial, and Global Regulatory teams.
• - Maintain strong relationships with health authorities and support regulatory inspections and inquiries.
• - Provide regulatory guidance for new products, launches, and portfolio activities.
• - Monitor regulatory changes and assess their potential impact on the business.

Requirements

• - Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, or a related field.
• - Minimum 3 years of experience in Regulatory Affairs within the pharmaceutical industry.
• - Experience with regulatory submissions and health authority interactions.
• - Strong knowledge of applicable pharmaceutical regulations and compliance requirements.
• - Advanced English proficiency.
• - Strong communication, project management, analytical, and stakeholder-management skills.
• - Ability to work effectively in a multinational and cross-functional environment.

What we offer

• - Opportunity to join a leading multinational pharmaceutical organization.
• - International and cross-functional exposure.
• - Professional growth and development opportunities.
• - Competitive compensation and benefits package.

Location: Mexico City

Work model: Hybrid