Regulatory Affairs- Manager- Pharmaceutical Industry

Role & responsibilities

1. Filing the ANDA ECTD dossiers independently.

2. Should have good communication skills both verbal and written.

3. Draft CC for FDA submission.

4. Should have proven track record for no RTR.

5. Solid dosage form such as Tablets, Capsules and other complex dosage form such as dossier filing of products with invitro studies and Biowavier approach.

6. Filing eCTD for other stringent regulatory countries such UK an other EU countries will be considered as an additional advantage.

7. Para IV filing, NDA 505b(2) and suitability of petition will be considered for best suit.

8. Should have experience in handling PharmaREADY software for dossier filing to US, UK and other ROW countries.

9. Good exposure in evaluating the dossier for purchase with proper du diligence.

10. Respond FDA for IR and CR as well other queries reasied by FDA till the dossier approval.

11. Should able to file CBE30 and PAS independently with proper assessment against the FDA SUPAC guidance.

Preferred candidate profile

• Minimum 10years in regulatory affairs department for US market ANDA filing.
• Experiences in dossier filing for Europe through Centralized.
• Procedure is essential with good communication skill verbal and written. Exposure in CMC for dossier preparation.
• Tablets and Capsules is must. Exposure to other markets such as UK, US and GCC countries will be an added advantage.

Perks and benefits

ALL INCL