Overview
The Project Manager, Regulatory Affairs, plays a pivotal role in driving APACMed's Regulatory Affairs (RA) agenda across the Asia-Pacific region. The position involves managing complex RA initiatives, fostering collaboration among stakeholders, and ensuring the successful delivery of high-impact projects aligned with the association’s strategic goals. This role requires a proactive mindset, and the ability to navigate and influence policies that enhance patient access to innovative medical technologies.
Key Responsibilities
Committee Agenda and Leadership:
- Lead the development and execution of the RA Committee's agenda, ensuring alignment with APACMed’s broader strategic priorities.
- Spearhead workstreams and initiatives within the RA Committee’s purview, from inception to completion.
- Collaborate with senior members to define project objectives and craft actionable plans to deliver measurable outcomes.
Stakeholder Engagement and Collaboration:
- Build and maintain relationships with key stakeholders, including regulators, policymakers, healthcare providers, and industry leaders, to advance committee goals.
- Serve as a primary liaison between APACMed members and external partners to ensure alignment and effective communication.
Policy Advocacy and Regulatory Harmonization:
- Lead the drafting of position papers, advocacy materials, and white papers to address regulatory gaps and opportunities.
- Represent APACMed in regulatory discussions to advocate for harmonized, patient-focused regulatory practices across the region.
Project Management:
- Manage multiple RA initiatives simultaneously, ensuring that timelines and deliverables are met with precision.
- Oversee project budgets, milestones, and stakeholder expectations to drive successful outcomes.
- Provide operational support for key APACMed regulatory initiatives, including SaMD, e-labeling, and post-market surveillance.
Event Planning and Coordination:
- Organize and execute RA-focused workshops, roundtables, and forums, managing all aspects of event logistics, speaker engagement, and post-event documentation.
- Develop summary reports and insights from events to share with stakeholders and members.
Regulatory Intelligence and Analysis:
- Monitor and analyze regulatory developments across APAC markets, compiling insights to inform strategic priorities.
- Provide actionable recommendations to the RA Committee and APACMed leadership based on trends and emerging issues.
Qualifications and Skills
Educational Background:
Advanced degree in Biomedical Sciences, Medical Sciences, Regulatory Affairs, Public Health, Health Policy, or a related medical/scientific discipline.
Experience:
- Minimum of 5 years of professional experience in regulatory affairs, policy advocacy, healthcare strategy, or a related field, with a preference for regional roles in the MedTech or broader healthcare industry.
- Candidates with regulatory affairs experience or a background in medical sciences/consultancy are encouraged to apply.
- Proven track record of managing cross-functional projects and engaging with diverse stakeholder groups.
Skills and Competencies:
- Strong project management and organizational skills, with an ability to juggle multiple priorities in a fast-paced environment.
- Exceptional analytical and writing capabilities to produce high-quality policy documents and reports.
- Excellent communication and presentation skills, with the ability to articulate complex regulatory concepts clearly and concisely.
- Knowledge of global and regional regulatory frameworks in MedTech, including SaMD and e-labeling.
- Proficiency in Microsoft Office tools, project management software, and data visualization platforms.
Personal Attributes:
- Independent and self-motivated, with a strong sense of accountability.
- Collaborative team player who can work effectively across cultures and organizational hierarchies.
- Proactive problem solver with meticulous attention to detail.
Working at APACMed
This position offers unique opportunities to work closely with senior leaders from the world’s largest MedTech companies, as well as regulators and stakeholders across the region. The role provides exceptional visibility within the industry, fostering professional growth and meaningful impact in shaping the regulatory landscape in APAC.
