Strategic Regulatory Expert

2 weeks ago

Singapore beBeeRegulatory Full time $90,000 - $120,000
**Regulatory Affairs Director Role Overview**

This senior leadership position is responsible for overseeing regulatory projects from inception to completion.

The successful candidate will ensure a deep understanding and application of regulatory strategies in various markets.

  • Craft and execute regulatory program strategies to ensure efficient submission planning and execution.
  • Direct and manage cross-functional teams for regulatory submissions, fostering relationships with senior leaders 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 regional regulatory teams, 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 commencement to their conclusion.

Requirements:

To be considered for this role, you must have:

  • A Bachelor's degree in a scientific or related field.
  • 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.
  • An extensive understanding of regulatory requirements and guidelines within the Asia Pacific region, adaptable to the regulatory environments of expanding markets.
  • A proven ability to lead and manage cross-functional teams and navigate complex regulatory submissions from inception to completion.
  • Superior project management skills, with a history of achieving key project milestones and delivering projects to completion.
  • Strong leadership and communication abilities, capable of influencing senior stakeholders and leading a team in a high-performance culture.
  • A commitment to professional development of team members, with a track record of mentoring and driving performance.
  • Excellent organizational skills to manage multiple projects simultaneously, ensuring attention to detail and a solution-oriented mindset.

Desirable Skills:

Prior experience in the following areas would be highly beneficial:

  • Mentoring
  • Pharmaceutical Industry
  • Management Skills
  • Leadership
  • Regulatory Affairs
  • Strategy
  • Adaptable
  • Compliance
  • Project Management
  • Attention to Detail
  • Regulatory Requirements
  • Stakeholder Management
  • Regulatory Submissions

About This Opportunity

This role offers a unique chance to lead regulatory initiatives and drive success in a dynamic environment.

We encourage applicants with a passion for regulatory affairs and a desire to make a meaningful impact.

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