Regulatory Affairs Manager

Zuellig Pharma; Parañaque; On-site; PHP 1,200,000 - 2,100,000; Full time

Job summary

Zuellig Pharma in the Philippines seeks a Regulatory Affairs Manager to lead regulatory activities for pharmaceutical and healthcare products. You will evaluate dossiers, ensure compliance, and coordinate with FDA-related bodies and cross-functional teams to support speed to market.

Applicants should have a BS Pharmacy and a valid pharmacist license, with 3–5 years of managerial Regulatory Affairs experience.

Qualifications

• BS Pharmacy and licensed pharmacist.
• 3–5 years of managerial experience in regulatory affairs.

Responsibilities

• Prepare and evaluate dossiers and technical documents for new products submissions.
• Ensure regulatory compliance throughout product lifecycle.
• Identify risks that may affect regulatory plans and timelines.
• Develop regulatory strategies to drive competitive advantage.
• Coordinate with stakeholders on regulatory status and updates.

Skills

Regulatory Affairs

Regulatory Strategy

Stakeholder Management

Dossier Preparation

Education

B.S Pharmacy, Licensed Pharmacist

Job description

Job Description

• Evaluation and preparation of dossiers and technical documents for submission of new pharmaceutical and healthcare products
• Ensure regulatory compliance of pharmaceutical and healthcare products throughout the product's lifecycle
• Identify risks and gaps that may impact implementation of local regulatory and commercialization plans
• Develop innovative regulatory strategy to drive competitive advantage
• Communicate and coordinate with various stakeholders (partners, cross-functional team, regional team, etc.) on regulatory status and updates
• Represent company with various Regulatory Health Authorities (FDA, PDEA, BAI, etc.)
• Prepare and review of artworks and labels for packaging artworks
• Review materials and ensure compliance through Veeva
• Execute key regulatory actions to support business requirements
• Ensure adherence to current and new regulations
• Cascade relevant and new regulations from governing bodies
• Ensure database, reports, trackers are updated and provided on time
• Provide support to the Regulatory Affairs Director in terms of regulatory strategy and regulatory intelligence to ensure speed to market of products and compliance with regulatory guidelines.
• To provide regulatory training as required by the cross functional team.
• Create SOPs, process updates to support regulatory function.
• Active representation of the company with trade associations and ensure key company advocacies are pushed across.

Qualifications

• B.S Pharmacy graduate and Licensed Pharmacist
• At least 3 to 5 years managerial experience in Regulatory Affairs