Urgent required Executive for Regulatory Affairs at Ahemdabad location. (For API)
Greetings from Raks Pharma Pvt. Ltd., (Group of Amneal Pharmaceuticals)
Please find the Job description as per following and revert to us if anybody intrested for Ahmedabad location.
1. Compilation / preparation and review of US DMF in CTD format, the documents needed for Regulatory submissions.
2. Preparation of Annual reports / Amendments /
Applicant’s Part & Restricted part US DMF / technical
3. Based on requirements, review/sign of Change controls, specifications and Test procedures of Raw materials, Packing materials, In-process, Intermediates & Finished products.
4. Support to prepare computer generated documents with respect to RA documents. 5. Communication to the respective department heads/
designees for regulatory filing documents within time and regular follow-up.
Please send your CV to harshad.bhavsar@rakspharma