Global Regulatory Compliance Manager

3 days ago

Singapore beBeeCompliance Full time $90,000 - $120,000

Regulatory Affairs Expert

The Regulatory Affairs Specialist will play a key role in the organization's success, responsible for all aspects of regulatory responsibilities in Singapore and Malaysia.

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 combine knowledge of scientific, regulatory, and business issues to enable products to meet required legislations in applicable markets. This requires expert knowledge, understanding and application of principles, concepts and practices of government regulations.

Main Responsibilities:

  • Ensure 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.

  • Associate/ Senior Associate, Regulatory Compliance

    2 weeks ago

    Singapore IQ EQ REGULATORY COMPLIANCE (SINGAPORE) PTE. LTD. Full time

    Manage a portfolio of clients - Provide advisory and consultancy services to clients - Submit and/or review of regulatory filings and notifications - Liaise and correspond with MAS and auditors - Periodic compliance reporting to senior management or board of directors - Provide or review compliance manual - Provide or review compliance checklists, registers,...

  • Compliance Manager

    2 weeks ago

    Singapore IQ EQ REGULATORY COMPLIANCE (SINGAPORE) PTE. LTD. Full time

    **Position Summary**: Support and assist IQEQ’s investment adviser client by providing regulatory compliance services through oversight of the execution and continuous improvement of the client’s compliance program, which meet the requirements of SEC Rules 206(4)-7 and 38a-1, including other state and federal securities laws and regulations. Update the...

  • Global Regulatory Compliance Specialist

    4 days ago

    Singapore beBeeCompliance Full time $80,000 - $120,000

    We are seeking a highly skilled Compliance Manager to join our team in Singapore.In this role, you will be responsible for ensuring our operations comply with MAS regulations, internal compliance policies and international standards across our global activities.Key Responsibilities:Ensure operational compliance with MAS regulationsMaintain internal...

  • Global Regulatory Compliance Lead/director

    3 days ago

    Singapore Wise(formerly Transferwise) Full time

    **Office**: Singapore **Team**: Compliance Since 2011, we’ve had a clear mission: money without borders. Built by and for people who live global lives, we’re the fairest, easiest way to manage your money across borders. We’re just at the beginning of our story and we’re growing at an incredible pace. We won’t stop until anyone, anywhere can...

  • Global Regulatory Compliance Lead/director

    3 days ago

    Singapore Wise Full time

    Since 2011, we've had a clear mission: money without borders. Built by and for people who live global lives, we're the fairest, easiest way to manage your money across borders. We're just at the beginning of our story and we're growing at an incredible pace. We won't stop until anyone, anywhere can send, spend and receive money wherever they are, whatever...

  • Global Regulatory Compliance Expert

    1 week ago

    Singapore beBeeCompliance Full time $80,000 - $120,000

    Regulatory Affairs Specialist">We are seeking a detail-oriented and highly motivated professional to fill the role of Regulatory Affairs Specialist. In this position, you will be responsible for ensuring compliance with global regulatory requirements for the development, approval, and marketing of pharmaceutical products.">Key Responsibilities:">">Manage...

  • Compliance Manager

    7 days ago

    Singapore Global Payments Full time

    Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and achieve amazing results....

  • Global Regulatory Compliance Specialist

    1 week ago

    Singapore beBeeRegulatory Full time $120,000 - $180,000

    We are seeking a skilled Regulatory Affairs Professional to play a critical role in ensuring global compliance with regulatory requirements for pharmaceutical products.Key Responsibilities:Manage the submission and approval process for applications such as Manufacturing License Applications (MLAs), Technical/Site Transfer Applications, and Marketing...

  • Senior Regulatory Compliance Manager

    5 days ago

    Singapore beBeeRegulatory Full time $150,000 - $250,000

    Regulatory Compliance Leader JobThe successful candidate will be responsible for delivering on the regulatory engagement strategy and maintaining our licensing responsibilities for regulated financial services entities across Asia.Key Responsibilities:Lead a team within the Global Regulatory Compliance Team to oversee regulatory compliance initiatives in...

  • Compliance Manager

    7 days ago

    Singapore Global payments Full time $90,000 - $120,000 per year

    Compliance Manager Every day, Global Payments makes it possible for millions of people to move money between buyers and sellers using our payments solutions for credit, debit, prepaid and merchant services. Our worldwide team helps over 3 million companies, more than 1,300 financial institutions and over 600 million cardholders grow with confidence and...