Owner at SaplingsHR
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Director - Regulatory Affairs - Life Sciences (15-20 yrs)
Regulatory Work :
1. Provide strategic input and technical guidance on regulatory the framework of the sector
2. Develop regulatory strategies and update based upon regulatory changes.
3. Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
Project Development :
- Create project plans and timelines. Must be able to juggle multiple and competing priorities and think analytically with good problem-solving skills.
Stakeholder Engagement :
- Engage with Industry; Government; anticipate regulatory and related obstacles and emerging issues of the sector to develop solutions
Research Work :
- Perform primary as well as secondary research for sourcing content for projects, ensure high quality of notes, PPTs, Talking Points, documents
Educational Experience: Masters in Pharmaceuticals/ Biotechnology
Must Have Skills :
- Strong knowledge of Regulatory guidelines, policies, standards, practices, Domestic regulatory guidelines, policies and regulations.
- Excellent written and verbal communication skills.
- Excellent analytical and problem-solving skills.
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