Manager - Regulatory Affairs - Digital Health Startup

About us :

We are an early stage digital health startup (currently operating in stealth mode), focusing on improving access to healthcare. We are looking for someone who is passionate about healthcare and about scaling businesses.

Role & responsibilities :

- Assess the regulatory landscape and requirements in target markets

- Assess healthcare systems in target markets and recommend go-to-market business models

- Plan and implement regulatory strategies for market entry

- Review and complete the regulatory requirements to setup and manage operations in target markets, including procuring licenses, registrations, preparing & submitting documents, meeting officials, seeking approvals, etc.

- Prepare, compile, file, and manage necessary dossiers/documents for regulatory authorities

- Respond to any regulatory queries and requirements received from authorities

- Ensure regulatory compliance, accuracy & timely completion, and quality control in all regulatory procedures

- Contribute to continuous development and improvement of products/services to achieve business vision and goals

- Prepare monthly reports and status updates on all regulatory topics

- Keep abreast of new regulatory developments in all markets

- Set internal policies and procedures that comply with regulatory requirements and industry codes of conduct

- Any other responsibilities as needed

Requirements :

- Degree in Medicine or Pharmacy from a premier university, with at least 5 years of work experience in regulatory affairs

- Prior experience in handling regulatory affairs for prescription and non-prescription drugs for multiple Asian markets will be an advantage

- Understanding of commercial concepts to provide relevant regulatory insights for achieving business goals

- Experience in document writing, review, and filing for various regulatory agencies

- Be resourceful and have an entrepreneurial mindset

- Flexibility and adaptability to changes and uncertainty

- Be comfortable working in a lean and fast-paced, tech startup environment

- Be a self-driven leader who takes ownership and leads by example

- Ability to work independently as well as a team - communicate openly, respect diversity of thoughts and ideas, and collaborate with openness, fairness and integrity

- Excellent verbal, written, and interpersonal communication skills

- Fluent in English (written and spoken). Proficiency in other language(s) preferred

There will be a basic remuneration and bonus based on individual and company performance. You will be part of the founding team, so the right candidate will have enormous opportunities for growth.