Regulatory Affairs Jobs at Sain Medicaments | Apply Now
Regulatory Affairs Jobs at Sain Medicaments Pvt. Ltd., a trusted name in pharmaceutical formulation and healthcare manufacturing, is hiring a Jr. Executive – Regulatory Affairs professional at its Uppal. With a legacy of quality and innovation since the 1970s, Sain Medicaments is ISO 22000:2005, WHO-GMP, and GLP certified, offering a strong platform for pharma professionals looking to advance their careers in global regulatory compliance and documentation. Apply for MSc Chemistry Jobs Excecutive Roles.
- Experience: 2-3 years of experience.
- Qualification: MSc Chemistry
- Industry: Pharmaceutical Manufacturing.
About the Company:
Sain Medicaments Pvt Ltd is a leading pharmaceutical formulation company, proudly serving human healthcare since the 1970s. We have come a long way to make a mark in the healthcare industry, with an ISO 22000:2005, WHO GMP, and GLP-certified manufacturing unit in Hyderabad.
Opening for: Jr. Executive Regulatory Affairs
Job Duties:
- Preparation of regulatory dossier for various countries. Coordinate and collect data/documents from various departments in the plant and review the same for compliance before preparation of dossiers.
- Contact API vendors and manufacturers for DMFs/APIMFs/Tech packs. Review the documents and ensure its compliance as per the CTD requirements.
- Co-ordinate with graphic designer for labels and packaging material artworks development.
- Plan for samples for registration in coordination with concerned departments and ensure its readiness as per the submission plan.
- Handling of queries received from clients, drug authorities and ensure required further information/documents in stipulated timelines.
The candidate should know the following:
- Explaining regulations, policies, or procedures
- Ensuring adequate compliance with regulations
- Advising others on matters that are related to regulatory processes and compliance
- Providing correct and accurate technical review of data or reports
- Overseeing the planning, coordination, and management of regulatory documentation activities
- Examining, identifying, and interpreting relevant regulatory guidelines
- Analyzing and evaluating laws and regulations that apply to the process of determining the impact on company activities
- Compiling and overseeing the maintenance of regulatory documentation databases or systems
- Coordinating efforts that are related to the preparation of regulatory documents or submissions
- Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, clarification, and follow-up on submissions still under review.
