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Pharmaceutical Regulatory Compliance Officer

Pharmaceutical Regulatory Compliance Officer

SAIN MEDICAMENTS PVT. LTDUppāl, Republic Of India, IN
1 day ago
Job description

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
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    Compliance Officer • Uppāl, Republic Of India, IN