Are you a seasoned professional in regulatory affairs with a passion for the pharmaceutical industry? Sain Medicaments Pvt. Ltd, a leading pharmaceutical formulation company, is hiring for the position of Regulatory Affairs Specialist in Hyderabad, Telangana. This is an excellent opportunity to join a company with a legacy of over 50 years in human healthcare and contribute to its global regulatory compliance efforts.
About Sain Medicaments Pvt. Ltd
Sain Medicaments Pvt. Ltd has been a trusted name in the pharmaceutical industry since the 1970s. With an ISO 22000:2005, WHO GMP, and GLP-certified manufacturing unit located in Hyderabad, the company is committed to delivering high-quality healthcare solutions. Sain Medicaments is dedicated to innovation, compliance, and excellence, making it a preferred partner in the global pharmaceutical market.
Job Title: Regulatory Affairs Specialist
Location: Uppal, Hyderabad, Telangana
Job Type: On-site, Full-time
Experience: 4-5 years
Qualification: B.Pharmacy, M.Pharmacy, MSc, or Pharma D
Job Description
As a Regulatory Affairs Specialist at Sain Medicaments, you will play a pivotal role in ensuring compliance with global regulatory standards. Your responsibilities will include:
- Regulatory Dossier Preparation:
- Prepare and compile regulatory dossiers for various countries.
- Coordinate with internal departments to collect and review data/documents for compliance.
- Vendor and API Coordination:
- Liaise with API vendors and manufacturers to obtain DMFs, APIMFs, and tech packs.
- Ensure all documents comply with CTD (Common Technical Document) requirements.
- Artwork Development:
- Collaborate with graphic designers to develop labels and packaging material artworks.
- Sample Management:
- Plan and coordinate the preparation of registration samples with relevant departments.
- Query Handling:
- Address queries from clients and regulatory authorities promptly.
- Ensure the submission of required information/documents within stipulated timelines.
- Regulatory Compliance:
- Interpret and apply relevant regulatory guidelines.
- Analyze laws and regulations to assess their impact on company activities.
- Documentation Management:
- Maintain and update regulatory documentation databases.
- Coordinate the preparation and submission of regulatory documents.
- Communication with Regulatory Agencies:
- Build and maintain strong relationships with regulatory agencies.
- Provide pre-submission strategies and follow up on submissions under review.
Key Skills and Knowledge
- In-depth understanding of regulatory processes and compliance.
- Ability to interpret and apply regulatory guidelines effectively.
- Strong technical review skills for data and reports.
- Excellent communication and coordination abilities.
- Proficiency in managing regulatory documentation systems.
Why Join Sain Medicaments?
- Be part of a globally recognized pharmaceutical company with a legacy of excellence.
- Work in a state-of-the-art, ISO and WHO-certified manufacturing facility.
- Opportunity to contribute to global healthcare solutions and regulatory compliance.
- Collaborative and growth-oriented work environment.
