Global Regulatory Affairs Manager

7 days ago

Singapore beBeeRegulatory Full time

Regulatory Affairs Specialist Job Overview

This is a key role within the organization responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.

The specialist will combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislations in applicable markets. This includes 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.

The specialist will have market & business level influence and responsibility, and be considered a key opinion leader and expert resource externally on all regulatory matters in applicable markets. They will actively influence changing regulations and guidance, interface with external regulatory agencies and trade associations, and provide executive management with regulatory metrics/information.

Main Responsibilities:

  • Responsible for ensuring regulatory compliance in 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.
  • Identify and address risks and business requirements. Ensure the development and implementation of leading-edge systems and best practices both internally and across sites or company-wide.
  • Provide project leadership or participate as a team member on major initiatives that have high impact to the business.
  • Support coordination and back up coordinator to ensure smooth operation and effective use of the Veeva system within the organization.

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.

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