Regulatory Affairs Director

3 days ago

Singapore RXILIENT MEDICAL PTE. LTD. Full time $150,000 - $250,000 per year

Job Description

  • Lead the oversight of regulatory projects from inception to completion within the assigned portfolio, ensuring deep understanding and application of regulatory strategies in the Asia Pacific and future global markets
  • Craft and execute regulatory program strategies to ensure efficient submission planning and execution, with a keen focus on guiding projects from initial concept to market delivery.
  • Direct and manage cross-functional teams for regulatory submissions, fostering relationships with senior leadership and ensuring regulatory milestones are met.
  • Monitor the development of regulatory submission plans for pivotal projects/products, maintaining a clear trajectory from inception through to successful project completion.
  • Provide strategic leadership to the Regional Regulatory team, Health Authorities, and external partners, ensuring quality and compliance in all outsourced activities.
    Act as a mentor and coach, empowering team members with enhanced skills in project management, publishing, and regulatory practices, driving projects from their commencement to their conclusion.

Requirements

  • Possess a bachelor's degree in a scientific or related field.
  • Bring a minimum of 10 years of regulatory affairs experience within the pharmaceutical industry, with a substantial focus on managing the full lifecycle of regulatory strategies and submissions.
  • Demonstrate an extensive understanding of regulatory requirements and guidelines within the Asia Pacific region, adaptable to the regulatory environments of the expanding MENA market.
  • Have a proven ability to lead and manage cross-functional teams and navigate complex regulatory submissions from inception to completion.
  • Exhibit superior project management skills, with a history of achieving key project milestones and delivering projects to completion.
  • Maintain strong leadership and communication abilities, capable of influencing senior stakeholders and leading a team in a high-performance culture.
  • Display commitment to professional development of team members, with a track record of mentoring and driving performance.
  • Utilize excellent organizational skills to manage multiple projects simultaneously, ensuring attention to detail and a solution-oriented mindset.

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