Founder at Digital Health Startup (Stealth Mode)
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Regulatory Affairs Manager - Digital Health (5-10 yrs)
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, creating awesome customer experiences, building relationships, and scaling businesses.
Key Responsibilities
1. Driving all activities related to regulatory affairs for the company
2. Understanding the business vision and objectives
3. Understanding the relevant regulatory environment and regulatory requirements for launching and growing products/services in India and other countries
4. Formulating and proposing actionable regulatory recommendations for market entry and launch of new products and services
5. Developing and implementing the regulatory action plan for market entry and launch of new products and services as planned by the company
6. Completing all regulatory requirements for market entry and launch of new products and services within the required timelines
6. Completing all regulatory documents required for the platform and successful business operations within the required timelines
7. Acquiring relevant licenses, registrations, and approvals required for products/services and business operations within the required timelines
8. Hustling if and when necessary to get necessary documents, licenses, registrations, approvals, etc, in order to achieve goals and timelines
9. Closely monitoring the regulatory environment, thinking ahead to anticipate any changes, and proactively proposing strategies to not only prevent any unfavorable impact on business or operations but to leverage on those opportunities
10. Setting up regulatory frameworks and processes in the company
11. Other responsibilities as required
Key Requirements
- Degree in Pharmacy
- At least 5 years hands-on experience in regulatory affairs at a large pharmaceutical organization
- Upto 5 years of team management/leadership experience
- Hands-on experience in completing documentation and acquiring regulatory license, registrations, approvals, etc.
- Hands-on experience in developing and implementing regulatory strategies and action plans
- Hand-on experience in setting up internal regulatory frameworks and processes
- Prior experience in a digital health startup will be an added advantage
- Self-driven leader who takes ownership and leads by example
- Self-starter with the ability to understand requirements, think strategically about business priorities, and act proactively
- Excellent collaboration, persuasion, negotiation, and problem-solving skills
- Excellent written and verbal communication skills
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