Are you a Regulatory Affairs Expert looking for an exciting opportunity in the pharmaceutical industry? Stallion Laboratories Pvt. Ltd. is calling for applications to join our Regulatory Affairs team at our Corporate Office in Ahmedabad, Gujarat.
Details About Stallion Labs Pvt. Ltd. Hiring
- Website: https://www.stallionlabs.com/
- Company: Stallion Laboratories Pvt. Ltd.
- Department: Regulatory Affairs
- Job Title: Senior Manager/Associate Director – Regulatory Affairs
- Experience: 02-15 Year
- Markets: US, EU, UK, Canada, China, Australia
- Batch: NA
- Salary: Competitive (Salary is no bar for potential leaders)
- Location: Corporate Office, 8th Floor, Devpath, B/H Super Mall, Near Lal Bunglow, Navrangpura, Ahmedabad, Gujarat 380009
- No Of Vacancies: Not Disclosed
- Opening Date: 06th January 2024
- Subject Line: Regulatory Affairs – Application for Senior Manager/Associate Director Position
About Stallion Laboratories Pvt. Ltd.
Stallion Laboratories Pvt. Ltd. is a leading global pharmaceutical company, operating in over 70 countries. Committed to excellence, we are expanding our presence and seeking dynamic individuals to join our Regulatory Affairs team to further strengthen our footprint in regulated markets.
Job Description
We are seeking experienced and dynamic Regulatory Affairs professionals to manage the entire regulatory product life cycle in our regulated markets. As a Senior Manager/Associate Director, you will play a key role in providing strategic solutions, ensuring regulatory compliance, and contributing to the success of our global business.
Key Responsibilities:
- Manage the regulatory product life cycle in regulated markets (US, EU, UK, Canada, China, Australia).
- Provide White Paper Strategy to cross-functional teams (CFTs) from development to commercial launch.
- Handle ANDA, ANDS, IDL, and Dossier filing with high quality and compliance to current regulatory requirements.
- Stay updated on current regulatory trends and provide regulatory science awareness at the organizational level.
- Offer strategic solutions based on experience with different regulatory agencies.
- Manage clients and third-party partners on CMO projects.
- Demonstrate excellent project management, coordination, communication, and interpersonal skills.
- Assess regulatory impact on business continuity and provide tactical and strategic decisions during critical changes.
- Participate in regulated audits (preferred).
- Guide various teams on current regulatory requirements and provide technical knowledge for immediate implementation.
- Conduct periodic regulatory and technical training throughout the organization.
Qualifications:
- Proven experience in regulatory affairs within pharmaceuticals.
- In-depth knowledge of ANDA, ANDS, IDL, and Dossier filing processes.
- Strong understanding of regulatory impact assessment on business continuity.
- Experience in managing clients and third-party partners on CMO projects.
- Excellent project management, coordination, and communication skills.
- Exposure to regulated audits (preferred).
- Ability to provide strategic solutions based on regulatory expertise.
How to Apply
Interested candidates are invited to submit their CV to awrnish.patel@stallionlabs.com with the subject line “Regulatory Affairs – Application for Senior Manager/Associate Director Position.”
