Regulatory Affairs Specialist
4 weeks ago
Company Overview
Pharmabharat is a Clinical Research Organization (CRO) dedicated to advancing clinical trials in the healthcare industry. With its headquarters in Maharashtra, our team of 11-50 employees is committed to supporting innovative healthcare solutions.
Job Overview
We are seeking a highly skilled Regulatory Affairs Trainee to support our team in regulatory compliance and submission activities. 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.
Key Responsibilities
- 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.
Requirements
- Regulatory Compliance: Profound understanding of regulatory frameworks within the pharmaceutical industry essential.
- FDA Regulations: Familiarity with FDA guidelines and processes for new drug approvals is critical.
- Pharmaceutical Regulations: 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.
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