Regulatory Manager, APAC

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Assistant Manager, Recruitment, AccountStaff

The primary role of the REGULATORY MANAGER, ASIA PACIFIC is to oversee the product registrations and regulatory pathways in Asia Pacific. He/She works with other stakeholders to create effective business and project implementation plans. He/She needs to ensure compliance with Asia Pacific regulations.

In this role, you will influence key decision-making processes with ample opportunities for enterprise-wide impact, exposure, learning and development.

Responsibilities

• Regulatory strategy and submission for Oncology, Nutrition and CNS products in Asia Pacific
• Independently manages and executes all aspects for the successful preparation, submission and timely approval of applications, variations, post-approval reporting obligations and general product life cycle management of assigned programs
• Develop, implement and maintain regulatory strategies for the products in line with the Company’s global objectives and local requirements
• Prepare, review and submit regulatory dossiers to the Asia Pacific regulatory bodies
• Effectively communicates the regulatory strategies, submission plans and timelines; impact assessment of trends, regulations and changes related to the assigned programs
• Manage the regulatory submission process, including timely preparation of submission documents and ensuring submission within project/ commercial launch timelines
• Regulatory compliance; ensuring compliance with Asia Pacific regulatory bodies
• Monitor regulatory changes and emerging trends in the space where the Company operates. Provide guidance to internal stakeholders on changes and impact
• Provide regulatory input into the development and marketing of the products, including clinical trial design, labeling and promotional material review
• Liaison with Regulatory Authorities: act as the primary point of contact with regulatory authorities, prepare and participate in meetings, answer queries, and negotiate approvals
• Maintain productive relationships with regulatory bodies to facilitate efficient approval processes
• Cross-functional Collaboration: work with clinical, medical affairs, manufacturing, quality assurance, and marketing to align regulatory strategy and project timelines
• Provide regulatory input to support clinical trials, product development, and post-market activities
• Support the preparation of regulatory documentation for product lifecycle management, including changes to product labeling, packaging, and marketing authorizations

Qualifications

• A degree in life sciences, pharmacy, or a related field preferred
• Minimum 8 years of regulatory affairs experience in the healthcare industry in Asia Pacific
• Experience with oncology clinical trials and regulatory requirements for investigational new drugs
• Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in development and lifecycle management
• Excellent communication and negotiation skills, both written and verbal, with the ability to engage effectively with regulatory agencies, cross-functional teams, and senior leadership
• Strong problem-solving skills and ability to navigate complex regulatory environments
• Demonstrated ability to manage multiple projects simultaneously with strong organizational skills
• Ability to work independently and as part of a collaborative team in a fast-paced environment

Seniority level

• Director

Employment type

• Full-time

Job function

• Quality Assurance and Other

Industries

• Pharmaceutical Manufacturing and Medical Equipment Manufacturing

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