Regulatory Affairs Trainee

Skills:
Regulatory Compliance, Documentation Management, Quality Assurance, FDA Regulations, Medical Device Regulations, Pharmaceutical Regulations, Regulatory Submissions, Regulatory Reporting,
Company Overview
Pharmabharat is a Clinical Research Organization (CRO) dedicated to advancing clinical trials in the Hospitals and Health Care industry. With its headquarters in Maharashtra, our team of 11-50 employees is committed to supporting cutting-edge healthcare solutions. For more information, visit our website at Pharmabharat.com.
Job Overview
We are looking for a Regulatory Affairs Trainee to join our team. This is a full-time position suitable for freshers with 0 to 1 year of experience. The job will be based in major cities, including Pune, Mumbai, Hyderabad, and Bangalore Urban. The trainee will be responsible for supporting regulatory compliance and submission activities in line with industry standards.
Qualifications And Skills

• Regulatory Compliance (Mandatory skill): Profound understanding of regulatory frameworks within the pharmaceutical industry essential.

• FDA Regulations (Mandatory skill): Familiarity with FDA guidelines and processes for new drug approvals is critical.
• Pharmaceutical Regulations (Mandatory skill): Must adhere to comprehensive pharmaceutical laws and regulations at all times.
• Documentation Management: Aptitude for maintaining and managing regulatory documentation accurately and methodically.
• Quality Assurance: Skills to ensure that all regulatory activities comply with quality assurance standards and practices.
• Medical Device Regulations: Understanding of regulations concerning medical devices and the ability to apply them to internal processes.
• Regulatory Submissions: Ability to support the preparation and submission of regulatory filings to local health authorities.
• Regulatory Reporting: Capable of assisting with regulatory reporting tasks, ensuring timely and accurate submissions.
  

Roles And Responsibilities

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• Assist in preparing and compiling necessary documents for regulatory submissions.
• Ensure compliance with regulatory policies and guidelines for all operations.
• Maintain up-to-date knowledge of global regulatory requirements and industry standards.
• Coordinate with internal teams to gather necessary information for submission processes.
• Participate in regulatory audits and implement corrective action plans as needed.
• Contribute to the development and maintenance of regulatory databases and systems.
• Support the development of strategies to streamline regulatory processes.
• Communicate effectively with cross-functional teams to ensure alignment on regulatory affairs objectives.