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