21/08 HR
Founder at Digital Health Startup (Stealth Mode)

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Lead - Regulatory Affairs - Startup (5-10 yrs)

Anywhere in India/Multiple Locations Job Code: 19034

About us :

We are a digital health startup that's focused on improving access to healthcare. We are looking for an experienced and entrepreneurial regulatory affairs professional. We are open to a full-time or part-time engagement.

Responsibilities :

- Assess the regulatory landscape and requirements for telemedicine in Asian markets

- Assess healthcare systems in target markets and recommend business models that may be adopted

- Provide insights and recommendations on decisions related to entering and operating a business in a new market

- Develop and implement market entry and launch strategies based on local regulatory requirements

- 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 various regulatory agencies in these markets

- 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 developing and offering services that align with business vision and goals

- Utilize experience and insights to continuously improve these services

- Prepare monthly reports and status updates on all regulatory topics

- Keep abreast of new developments in regulations across all critical health authorities in all markets

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

Requirements :

- Medicine or Pharmacy degree from a premier university

- Strong experience in regulatory affairs focusing on multiple Asian markets

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

- Experience practicing as a physician or pharmacist would be an added advantage

- Basic understanding of commercial concepts to integrate regulatory insights for achieving business goals

- Strong problem-solving skills

- Comfortable working in a fast-paced, tech startup environment

- Flexibility and adaptability to changes and uncertainty

- 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

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