Regulatory Affairs Associate

Job description

Sain Medicaments Pvt Ltd – Hyderabad

About the Company:

Sain Medicaments Pvt Ltd is a leading pharmaceutical formulation company, proudly serving Human healthcare since 1970s, we have come a long way to make a mark in the healthcare industry which has ISO 22000:2005, WHO GMP, GLP certified manufacturing unit situated at HYDERABAD.

Opening for: Jr. Executive Regulatory Affairs

Job Duties:

• Preparation of regulatory dossier for various countries. Co-ordinate and collect data/Documents from various departments in plant and Review of the same for the 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 co-ordination 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

Candidate should have knowledge of 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, or clarification, and follow-up on submissions still under review.

Experience:

• 2-3 years of experience.

Qualification:

• B.Pharmacy, M.Pharmacy, MSc, Pharma D.

Industry

• Pharmaceutical Manufacturing