Lead Regulatory Affairs Specialist

10 hours ago

Singapore beBeeRegulatory Full time $100,000 - $150,000
Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs professional to join our team in Singapore and Malaysia. As a key opinion leader, you will be responsible for all aspects of regulatory responsibilities across these markets.

The ideal candidate will have a strong understanding of scientific, regulatory, and business issues, enabling the development, manufacture, or distribution of products to meet required legislations. You will also direct and support regulatory-related matters such as new product registrations, change management, renewals, claims, advertisement and promotional materials review, labelling support, and external environment surveillance.

Your primary focus will be on combining knowledge to ensure compliance with local regulations and requirements. You will oversee global regulatory product development strategies, prepare and submit marketing approval applications, and ensure adherence to post-marketing approval requirements.

We are looking for an expert who can develop and advance our organization's policies and procedures related to regulatory affairs and compliance. This includes fostering a culture of adherence and regulatory integrity, interacting with internal and external stakeholders, and influencing policy in alignment with business strategies.

Key Responsibilities include:
  • Direct and support regulatory-related matters.
  • Combine knowledge to ensure compliance with local regulations and requirements.
  • Oversight of global regulatory product development strategies.
  • Ensure adherence to post-marketing approval requirements.
  • Develop and advance organizational policies and procedures.
  • Interact with internal and external stakeholders.

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.
  • Expert knowledge of government regulations.
  • Sound knowledge of regulatory and business strategies.
  • Ability to organize and analyze technical data.
  • Ability to work cross-functionally and manage multiple projects.

Benefits:

We offer a competitive salary and bonus, flexible working model, career opportunities, and endless amenities and benefits. Our company is a world-class MNC Healthcare organization empowered to tackle the world's toughest health challenges, innovate through science and technology, and transform patient care.


Others:

You will have the opportunity to explore new technology, learn new skills, enjoy a diverse and open culture, engagement, and care. We foster a culture of adherence and regulatory integrity, and we are committed to developing and advancing our organization's policies and procedures related to regulatory affairs and compliance.

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