Head Regulatory Affairs - Leading API Pharma - Aurangabad

Job Description

Dear Candidates, Greetings of the day! Harman Finochem Limited is an India-based Pharmaceutical Company catering to its clients across the globe, established by Late Mr. Bhupinder Singh Manhas in 1983, our core competencies are in manufacturing and exporting of Active Pharmaceutical Ingredients mainly Metformin HCl, Fenofibrate, Divalproex Sodium, Riboflavin Phosphate Sodium, Glycopyrrolate/Glycopyrronium bromide and more. We have two USFDA approved manufacturing facilities at Shendra & Chikalthana, Aurangabad. We are hiring for "Regulatory Head - API Division" for Shendra, Aurangabad location, who will be responsible for three API units. Role & responsibilities : 1. Responsible to review and submission of DMFs/E-DMFs/CEPs to US-FDA, Europe, EDQM, Health Canada, PMDA, China, Korea, Brazil and Rest of World. 2. Ensuring timely readiness of dossiers for all submissions. 3. Co-ordination with other departments to resolve the issues and queries related to submitted dossiers. 4. Quality and speedy response to the Regulatory agencies queries and Customer queries. 5. Conduct training on DMF compilation, submission and guidelines to build regulatory team of well-rounded professionals 6. Evaluation of manufacturers of staring material & primary packing material for use in Active Pharmaceuticals Ingredient. 7. Monitoring and communicating new and changing regulations to concern Department. 8. Maintenance of DMF fees and facility fees (self-identification) in accordance to GDUFA Evaluation of change controls and other documents. 9. Maintaining self-identification of our facilities & establishment renewal to US FDA. 10. Review and submission to drug listing (Label) of our API to US-FDA. 11. Maintaining the D&B renewal for our facilities. 12. Maintaining the life cycle of submitted DMFs, annual-updates, amendments and variation filings as per the stipulated timeline. Preferred candidate profile : Education : BSc/MSc Experience : 16 to 25yrs of experience in API Pharma Industry into Regulated market Good in Team Management Perks and benefits : As per company standard