Stallion Laboratories Hiring For Regulatory Affairs Department

We at Stallion Laboratories Pvt. Ltd. are going stronger globally in more than 70+ countries. As a part of expansion and to further strengthen our footprint in on-going business, we are aggressively looking for dynamic core REGULATORY AFFAIRS Experts for our REGULATED Markets.

Department: Regulatory Affairs

Location: Corporate Office

Markets: US, EU, UK, Canada, China, Australia.

Designation: Sr. Manager/ AGM

■ Salary is no bar for potential leaders.

Please send your cv on avnish.patel@stallionlabs.com and do specify subject line with Dept. Nane- Regulatory Affairs

Job Description:

■ Well Versed experience in managing entire regulatory product life cycle in listed regulated markets.

■ Providing White Paper Strategy to CFTs throughout life cycle starting from development, execution, filing to till approval followed by commercial launch.

■ANDA, ANDS, IDL and 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.

■ Keeping individual updated for all current regulatory trend and providing regulatory science awareness at organization level.

■ Expertise in providing Regulatory strategic solutions based on experience with different regulated Agencies to come out of box thinking.

■ Well versed experience of managing different clients, third party partners on CMO projects.

■ Excellent Project management, co-ordination, communication and interpersonal skills. Having a sound understanding on Regulatory impact assessment on business continuity and contingency perspective.

■ Providing tactical and strategic decision on managing critical changes during commercial level to ensure regulatory compliance is maintained.

■Exposure of participating in Regulated Audit is preferred.

■ Guiding ARD, F&D, Sourcing, QA, QC, Mfg. and Other teams on current regulatory requirements and providing technical knowledge on immediate implementation aspects.

■ Conducting periodic regulatory and technical training throughout organization.

Stallion Laboratories Hiring For Regulatory Affairs Department