Regulatory Affairs Executive
5 hours ago
**Position Title : Executive - Regulatory Affairs**
**Base Location : Delhi
- HO**
**Reporting To : Head - Regulatory**
**Role & Responsibilities**:
- **Plan & develop procedures to ensure regulatory compliance for the organization.**
- **Ensure that the organization's products comply with the regulations of the region where they want to distribute them**
- **Keep up to date with national and international legislation, guidelines and customer practices**
- **Represent the organization in front of regulatory authorities in the country (CDSCO, DGHS, DAHD, DCA, FSSAI etc.) as well as in front of the regulatory team of principals/distributors/dealers.**
- **Maintain audit compliance for the organization wherever necessary from regulatory point of view**
- **Post marketing surveillance reports compliance - sending out Field Safety Corrective Actions to customers and following up on the information, compiling information and sharing with the right stakeholders.**
- **Take part in the development of marketing concepts and approve packaging, labeling and flyers with respect to regulatory compliance**
**Experience: 0-3 years**
**Qualification**:
**Graduate in Life Sciences / Biology / Biotechnology or any science discipline, preferably BPharm.**
**Additional Requirements**:
- **Prior experience in IVD regulatory compliance will be an added advantage**
- **Attention to detail.**
- **Ability to work independently, as well as with cross-functional teams, including remote team members.**
- **Good proven written and verbal communication skills**
- **Efficient in multitasking**
- **Demonstrated ability to work within deadlines & with additional tasks.**
- **Good knowledge of MS office tools including MS Word, MS Excel, MS Powerpoint or similar tools.
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