Pasir Ris - Regulatory Affairs Director

apartmentRxilient Medical placePasir Ris scheduleFull-time calendar_month6/9/25

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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