Client Manager at MavenHasten Consulting India Pvt. Ltd.
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Regulatory Affair Specialist (8-12 yrs)
- Being there at the customer site, take time to explore and understand their regulatory challenges in filing their products
- Guide our customers to the right Client's Pharma documentation that they need for their registration
- Proactively advise customers on how to interpret the relevant regulations (e.g. QbD,DMFs, IID, LOA) and flag any risks to them that you may see coming up for them
- Customer requests for regulatory support are mainly for support with foreign regulatory filings. You will be successful if you have a real understanding of what customer needs to register their products, or you can help them access the required knowledge from their regulatory network and relevant external parties
- Developing standard slide decks on how to interpret e.g. FRCs, CMAs that can be shared with customers
- Being at conferences and providing regulatory seminars in the market
- Representing Client's Pharma in the relevant regulatory bodies and associations in the AsiaPacific region (e.g. IPEC India)
- Pro-actively define new their Pharma Policies on Regulatory Affairs and lead implementation of these.