About Company
VELOCITY CLINICAL RESEARCH, INC is a global organization that collaborates with biotechnology and pharmaceutical companies to expand research in new drugs, medical devices, and diagnostics, and the company’s vision is to improve the quality of human life with their effective discoveries and medical solutions. For more details about the company, please visit Velocity Clinical Research
Vacancy Details
- DESIGNATION – Regulatory Affairs Specialist
- DEPARTMENT – Regulatory Affairs
- DIVISION – Regulatory
- EXPERIENCE – Freshers & Experienced
What responsibilities will personnel be handling as a part of a team?
- Compile and file protocol updates, annual approval applications, noncompliance reports, evaluation and adverse event notifications, and another IRB-related submission.
- Assist in audit and inspection procedures by ensuring the accurate and timely submission of files.
- Manage the submission of SAE and AE to IRB within specified timelines.
- Perform necessary quality checks of the regulatory binder to help the site coordinators prepare the plan for monitoring visits, sponsor audits, and regulatory reviews.
- Remind staff members, the Site Manager, and the Director about training renewal deadlines.
- Prepare the protocol, consent form, HIPAA authorization, and Other related documents for IRB optimization.
- Share Copies of IRB documentation with sponsors, as required.
- Provide Support and Assistance in the submission of SAE and AE reports in a timely fashion.
- Interact and communicate with staff to complete financial disclosure forms for each conducted study.
What skills do I need to get this job?
- Good Understanding of Medical Terminologies.
- Comfortable working in a collaborative environment.
- Capable of adjusting based on clinical priorities.
- Strong Knowledge of ICH, GCP, and FDA regulatory standards.
- Ability to comply with the established guidelines.
- Detail Oriented and Multitasking.
What other requirements does Velocity Clinical Research ask for?
- Open to travel both locally and globally as needed.
- Able to sit and stand for an extended period.
- Capable of lifting weights to 30 pounds.
- Communicate with individuals both in person and via phone calls.
- Physical movement is very limited.
Eligibility Criteria
- 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.
- Technical degree holders, candidates with a minimum experience of 03 years in relevant fields are also eligible for the job.
Regulatory Affairs Specialist Salary
Velocity Clinical Research has not disclosed the salary figures but as per company standards and job profile. The Salary may vary between INR 3,00,000 to INR 6,00,000 per annum based on academic qualifications, Job profile, and expertise of personnel.
How to apply for the Regulatory Affairs Specialist Jobs?
The personnel will be working in the Velocity Clinical Research Company located in Hyderabad, Telangana, India, This is a Full-Time Job opportunity for individuals looking for jobs in the clinical research field. For more details please read the article carefully.
- Job Location – Hyderabad, Telangana, India
- Position Type – Full-Time / Regular
- Work Mode – Onsite
- Industry Type – Clinical Research Company
Interested candidates can apply for the post by filling out the application by clicking the link below. Candidates check all the details carefully before submission and be sure to upload your updated resume and cover letter highlighting your qualifications, experience, achievements, and contact information. Shortlisted candidates will be informed via mail or phone by the concerned HR department.
Application Link: Click Here
