Openings in Regulatory Affairs at Stallion Laboratories

Stallion Laboratories incorporated in 1988 as an integrated private sector Pharmaceutical Formulation Manufacturer, has acquired an unmatched record of managing niche product in formulations with a WHO GMP approved production facility and GLP qualified stringent quality control. The path of success lies in its belief of creativity and no negotiation with the quality of work. Stallion Laboratories Unit-ll a USFDA & UK-MHRA approved facility and proposed to be EU GMP approved plant. With its approval, Stallion aims to enter regulated markets.

Post : Deputy Manager / Manager / Sr. Manager

Department : Regulatory Affairs
Markets : EU, UK, Canada, ANZ, Saudi Arabia, UAE
Experience : 10 -12 Years
Salary is no bar for potential leaders

Job Description
1. Well Versed experience in managing entire regulatory product life cycle in listed regulated markets.
2. Providing White Paper Strategy to CFTs throughout life cycle starting from development, execution, filing to till approval followed by commercial launch.
3. ANDA, ANDS, IDLand Dossier filing with utmost quality and by complying all current regulatory requirements which includes but not limited to original filing, deficiency handling, post-approval variation /supplements filing.
4. Keeping individual updated for all current regulatory trend and providing regulatory science awareness at organization level.
5. Expertise in providing Regulatory strategic solutions based on experience with different regulated Agencies to come out of box thinking.
6. Well versed experience of managing different clients, third party partners on CMO projects.
7. Excellent Project management, co-ordination, communication and interpersonal skills.
8. Having a sound understanding on Regulatory impact assessment on business continuity and contingency perspective.
9. Providing tactical and strategic decision on managing critical changes during commercial level to ensure regulatory compliance is maintained.
10. Exposure of participating in Regulated Audit is preferred.
11. Guiding ARD, F&D, Sourcing, QA, QC, Mfg. and Other teams on current regulatory requirements and providing technical knowledge on immediate implementation aspects.
12. Conducting periodic regulatory and technical training throughout organization.