Global Regulatory Strategy Lead

Michael Page; Philippines; On-site; PHP 2,500,000 - 4,500,000; Full time

Benefits offered by this job

Competitive salary

International exposure

Career development and leadership成长机会

Job summary

Our client, a leading global pharmaceutical organisation, is seeking a seasoned Regulatory Strategy & Submissions professional to drive regulatory strategies across multiple regions. The role requires managing dossiers, liaising with health authorities, and guiding lifecycle activities from development through post-approval.

You will collaborate with Clinical Development, Medical Affairs, Pharmacovigilance, QA, Manufacturing, and Commercial teams to enable launches and market expansion.

Qualifications

• Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology, or a related discipline.
• 7+ years of Regulatory Affairs experience within the pharmaceutical industry.
• Experience leading regulatory submissions and approvals in multiple international markets.
• Expertise in regulatory submission processes and lifecycle management.
• Strong project management and stakeholder management skills.
• Strategic thinker with strong analytical and problem-solving capabilities.
• Excellent communication and influencing skills.
• Ability to manage multiple priorities in a fast-paced, matrixed environment.
• Collaborative leader with a strong attention to detail and commitment to compliance.

Responsibilities

• Develop and implement regulatory strategies to support product registration, label updates, lifecycle management, and market expansion activities.
• Lead the preparation, review, and submission of regulatory dossiers to health authorities across multiple regions.
• Ensure submissions comply with applicable regulations, guidelines, and industry standards.
• Manage regulatory timelines to support product approvals, launches, and business objectives.
• Serve as the primary regulatory contact for interactions with regulatory agencies.
• Coordinate responses to authority questions, deficiency letters, and information requests.
• Support regulatory inspections, audits, and compliance activities.
• Oversee post-approval regulatory activities, including variations, renewals, labelling updates, and product maintenance.
• Monitor and assess the impact of emerging regulations and evolving requirements on existing products.
• Provide strategic recommendations to mitigate regulatory risks.
• Partner with Clinical Development, Medical Affairs, Pharmacovigilance, Quality Assurance, Manufacturing, Supply Chain, and Commercial teams.
• Provide regulatory guidance throughout the product development and commercialisation lifecycle.
• Contribute to launch readiness planning and market expansion initiatives.
• Ensure regulatory processes and documentation are maintained in accordance with relevant regulations and company policies.
• Support the development and continuous improvement of regulatory systems, processes, and procedures.
• Maintain awareness of industry best practices and regulatory intelligence.

Skills

Regulatory strategy

Project management

Stakeholder management

Analytical thinking

Education

Bachelor's degree in Pharmacy, Life Sciences, Chemistry, Biotechnology

Job description

Our client, a leading global pharmaceutical organisation, is seeking a seasoned Regulatory Strategy & Submissions professional to drive regulatory strategies across multiple regions. The role requires managing dossiers, liaising with health authorities, and guiding lifecycle activities from development through post-approval.

You will collaborate with Clinical Development, Medical Affairs, Pharmacovigilance, QA, Manufacturing, and Commercial teams to enable launches and market expansion.