Position: Vice President, Regulatory Affairs
Geographical Focus: Southeast Asia and Taiwan, expanding to the MENA market
Responsibilities:
- 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.
Qualifications:
- Possess a bachelor's degree in a scientific or related field, with an advanced degree (e.g., PharmD, PhD) strongly preferred.
- Bring a minimum of 15 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.
