Regulatory Affairs Manager

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

Job Description: Zuellig Pharma is a leading healthcare solutions company in Asia, and our purpose is to make healthcare more accessible to the communities we serve. We provide world-class distribution, digital, and commercial services to support the growing healthcare needs in this region. The company was started a hundred years ago and has grown to become a multibillion-dollar business covering 17 markets with over 12,000 employees. Our people serve more than 200,000 medical facilities and work with over 450 clients, including the top 20 pharmaceutical companies in the world.

Purpose Of The Role

The Regulatory Affairs Manager is responsible for leading regulatory activities to ensure timely product registrations, lifecycle maintenance, and compliance of biologicals, vaccines, and healthcare products. The role develops and executes regulatory strategies that support business objectives, ensures adherence to evolving regulatory requirements, and serves as the key liaison with regulatory authorities and internal stakeholders to facilitate product commercialization and market access.

What You'll Do

• 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

Must-Have

What Will Make You Successful

• Bachelor's Degree in Pharmacy and a licensed Pharmacist.
• At least 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.

Advantage To Have

• Experience handling biologicals, vaccines, and specialty healthcare products.
• Experience developing and executing regulatory strategies in a commercial environment.
• Familiarity with artwork, labeling, and promotional material review processes.
• Knowledge of Veeva and electronic document management systems.
• Experience in regulatory intelligence and policy monitoring.
• Strong project management and cross-functional collaboration skills.
• Experience developing SOPs and conducting regulatory training.
• Active participation in industry associations or regulatory advocacy initiatives

What We Offer

• We are committed to fostering an inclusive environment where our employees can learn, grow, and achieve shared success.
• We champion diversity, equity, and inclusion, ensuring every individual feels valued, respected, and treated fairly.
• As a leading multi-market healthcare solutions provider, we empower our employees to gain comprehensive knowledge and expertise in the dynamic healthcare industry across the region.
• Enjoy the flexibility to effectively balance your work and personal life while taking charge of your career journey through our empowering growth opportunities.
• Our Total Rewards program is designed to support your overall well-being in every aspect.