About Company
VELOCITY CLINICAL RESEARCH, INC is an international organization that works with biotechnology and pharmaceutical companies to expand research in new drugs, medical devices, and diagnostics, focusing on enhancing the quality of human life with an active presence in various countries worldwide like the US and Europe. For more details about the company please visit https://velocityclinical.com/
VELOCITY CLINICAL RESEARCH, INC is hiring fresher candidates for the post of Regulatory Affairs Specialist. All details related to the job are mentioned below.
Regulatory Affairs Specialist Vacancy Details
- DESIGNATION – Regulatory Affairs Specialist
- DEPARTMENT – Regulatory Affairs
- DIVISION – Regulatory
Job Responsibility
- Draft and submit file changes, annual applications for authorization of ongoing protocols, evaluations, non-compliance reports, adverse event reports, and Other IRB submissions.
- Help in audit and inspection processes by ensuring the accurate and timely submission of files.
- Assist site coordinators in the preparation for monitoring visits, sponsor audits, and regulatory reviews by conducting detailed quality checks of the regulatory binder.
- Develop the protocol, informed consent form, HIPAA authorization, and Other related documents for IRB evaluation.
- Coordinate or assist in the submission of SAE and AE reports promptly.
- Coordinate with staff to complete financial disclosure forms for each study.
- Complete the other assigned task sincerely.
Skills Required
- Multitasking and Strong planning skills.
- Expertise in adhering to documented protocols.
- Knowledge of computer applications like MS Office Software, fax, and copier.
- Good Verbal and Oral Communication skills
- Strong Knowledge of ICH, GCP, and FDA regulatory standards.
Other Requirement
- Interact with the person face to face and via telephone.
- Capable of sitting or standing for extended periods.
- Walking is minimal
- Flexible to travel both locally and nationally.
Eligibility Criteria
- Candidates must have a Bachelor’s degree in Life Science, Pharmacy or other related field (B.Pharm / B.Sc)
- Minimum 01 years of experience is required in the life science industry.
- Candidates holding technical degrees with a minimum experience of 03 years in relevant fields are also eligible for the job.
Regulatory Affairs Specialist Salary & other Details
- The Salary may vary between INR 3,00,000 to INR 6,00,000 per annum (Estimated Salary)
Disclaimer: The salary figure mentioned is estimated from different websites like Glassdoor, AmbitionBox, etc.
Other Details
- Job Location – New Delhi, Pune, Mumbai, Hyderabad, Kolkata, Bengaluru
- Contract Type – Full-Time
- Work Mode – Onsite
- Industry Type – Clinical Research Company
How to apply for Regulatory Affairs Specialist Jobs?
- Candidates may apply for the post by filling out an application form using the given Link.
Application Link: Click Here
