COD Research
Are you a passionate professional looking to build a career in Regulatory Affairs? COD Research is offering an excellent opportunity for freshers and experienced candidates to join its team as Regulatory Affairs Executives. If you have a background in Pharmacy or Life Sciences, this role could be your stepping stone into the dynamic world of pharmaceutical regulations.
Why Choose a Career in Regulatory Affairs?
Regulatory Affairs is a crucial field in the pharmaceutical and healthcare industry. Professionals in this domain ensure that drugs, medical devices, and other healthcare products comply with national and international regulations. A role in Regulatory Affairs offers exposure to global regulatory frameworks, documentation processes, and opportunities to work closely with various departments, including research & development, quality assurance, and marketing.
COD Research is Hiring!!
Position: Regulatory Affairs Executive
Qualification: B. Pharm or M. Pharm / Graduate degree in life science background.
Experience: 0-2 Years
Job description
Position : Regulatory Affairs Executive
Department : Regulatory Affairs
Location : Ahmedabad
Key Responsibilities
- Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents
- Work with other departments and communicate the submission requirements when documents are needed for regulatory submission.
- eCTD Compilation
- Annual Report Writing for USFDA
- Product Transfer Support
- Maintain regulatory files. Maintain and update regulatory authorizations.
- Assure that appropriate maintenance of registrations occurs including renewals, listings, site registrations, supplements for changes (PAC) and annual reports.
- Support approval in other regions as required.
- Assist in preparing response to regulatory authoritys questions within assigned timelines.
- Stay abreast of regulatory procedures and changes in regulatory climate.
- Review and create product labels and review promotional material for compliance with applicable regulations and technical standards.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Other duties as assigned.
Qualifications & experience required
- B. Pharm or M. Pharm / Graduate degree in life science background.
Note: Immediate Joiners will be preferred.
Please go through the detailed job description given below.
Interested candidates may share their resume on [email protected]
OR
How to Apply?
Interested candidates can share their updated resumes at [email protected]. Don’t miss this opportunity to start or advance your career in Regulatory Affairs!
🚀 Apply now and be a part of COD Research’s dynamic team!
To apply for this job email your details to career@cod-research.com.
