Global Regulatory Expert

As a Regulatory Affairs Manager, you will be responsible for overseeing all aspects of regulatory responsibilities in Singapore and Malaysia. This includes combining knowledge of scientific, regulatory, and business issues to enable all products that are developed, manufactured or distributed to meet all the required legislations in the applicable markets.

Additionally, this role is responsible for directing and supporting regulatory related matters such as registration of new products, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.

This role has market & business level influence and responsibility, and is considered a key opinion leader and an expert resource externally on all regulatory matters in the applicable markets.

You will be actively called upon to influence changing regulations and guidance, interface with external regulatory agencies and trade associations and to provide executive management with regulatory metrics/information. Adheres to company policies, procedures, and supports department objectives.

Main Areas of Responsibility:

• Responsible for Singapore and Malaysia.
• Direct and support regulatory related matters such as growth & innovation and post-marketing Lifecycle Management (LCM) regulatory activities e.g., new product registrations, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.
• Oversee creation of global regulatory product development strategies and preparation & submission of marketing approval applications to health authorities to ensure that development plans meet global regulatory requirements.
• Ensure compliance with product post-marketing approval requirements.
• Develop and advance the organization's policies and procedures related to regulatory affairs and compliance to foster a culture of adherence and regulatory integrity.
• Interact with internal regulatory personnel, external trade association partners, and regulators to resolve regulatory matters ranging from pending application negotiations to proposed legislation and guidance document ramifications for the business.
• Participate in applicable external trade association or industry working groups to influence policy in alignment with business strategies.

Requirements:

• Minimum Degree in any Science course with minimum 5 years of experience.
• Proven experience in regulatory affairs within the pharmaceutical or medical device industry.
• Strong understanding of regulatory requirements and submission processes in the specified markets.
• Expert knowledge, understanding and application of principles, concepts and practices of government regulations.
• Sound knowledge of regulatory and business strategies to gain and maintain the legal marketing status of the product portfolio.
• Ability to organize and analyze technical data and identify issues or gaps.
• Ability to work cross-functionally and manage multiple projects.
• Excellent organizational and negotiation skills.

Benefits:

Competitive salary and bonus, and endless amenities and benefits, including a world-class organization trying your hands at something you have dreamt of doing. Get an opportunity to explore new technology, learn new skills, enjoy the diverse and open culture, engagement and care, flexible working model, career opportunities, and competitive salary and bonus, and endless amenities and benefits. You will also get the opportunity to work in a world-class MNC Healthcare company and contribute to making a difference in healthcare. As a valued member of our team, you will receive ongoing training and professional development to help you succeed in your role.

Others:

Determine and communicate submission and approval requirements. Communicate application progress to internal stakeholders. Compile, prepare, review and submit regulatory documents for product approval and registration with health authorities. Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies and complete all regulatory projects as assigned. Maintain up-to-date knowledge of regulatory requirements across different markets. Monitor and assess the impact of changing regulations on submission strategies. Manage product labelling in line with local regulatory guidelines. Review and approve advertisement and promotional materials to ensure compliance with local regulations and requirements. Assess acceptability of documentation for submission filing to comply with regulatory requirements for marketing applications, clinical trials and corporate goals, to secure submission approvals. Participate in new product development by offering insights and expertise on regulatory requirements, assessing global regulatory strategies, and recommending future strategies and actions. Coordinate with external trade association or industry working groups on regulatory.