COD Research, a leader in pharmaceutical research and regulatory solutions, is currently hiring for the position of Executive – Regulatory Affairs at their Ahmedabad facility. This is a fantastic opportunity for skilled professionals to advance their careers in the dynamic field of global regulatory compliance.
This article provides a complete overview of the Executive Regulatory Affairs job, including the job description, eligibility criteria, salary, and the application process.
About COD Research
COD Research has established itself as a trusted name in the pharmaceutical industry, renowned for delivering high-quality regulatory, clinical, and analytical research solutions. The company operates in strict compliance with the standards set by major global regulatory agencies like the USFDA, EMA, and WHO. With a firm commitment to innovation, accuracy, and integrity, COD Research offers a professional environment where talented individuals can thrive and make a significant impact on pharmaceutical development worldwide.
Job Description: Executive – Regulatory Affairs
As an Executive in Regulatory Affairs, you will be a key player in ensuring that the company’s products meet all international regulatory standards. Your work will directly contribute to the successful global submission of pharmaceutical products.
Key Responsibilities & Roles:
- Regulatory Submission Preparation: Compile, review, and format critical regulatory documents (such as IND, NDA, BLA, MAA) in eCTD format as per global health authority requirements.
- Quality Control: Perform meticulous document formatting, apply hyperlinks and bookmarks, and validate electronic submissions using advanced regulatory publishing tools to ensure 100% accuracy and compliance.
- Technical Management: Oversee the technical aspects of electronic submissions, troubleshoot publishing issues, and guarantee the timely delivery of submission packages.
- Regulatory Compliance: Stay abreast of the evolving ICH, USFDA, and EMA guidelines to ensure the company’s practices are always up-to-date.
- Submission Lifecycle Management: Track the progress of regulatory submissions and manage their timely electronic delivery through official regulatory gateways.
- Cross-Functional Collaboration: Work closely with regulatory leads, medical writers, and other teams to align workflows and meet project timelines.
- Documentation Archival: Maintain strict version control and securely archive all regulatory submission packages.
- Process Improvement: Actively contribute to initiatives aimed at enhancing regulatory workflows and efficiency.
Eligibility & Qualifications
Candidates interested in applying for this Regulatory Affairs job must meet the following criteria:
- Educational Qualification: B.Pharm, M.Pharm, or M.Sc in Pharmacy, Pharmaceutical Sciences, Chemistry, Biotechnology, or related fields.
- Experience: 2 to 4 years of relevant experience in Regulatory Affairs. Prior experience in Regulatory Publishing is highly preferred.
- Skills Required:
- Strong knowledge of global regulatory submission formats (e.g., IND, NDA, MAA, eCTD).
- Proficiency in using regulatory publishing software and tools.
- Familiarity with guidelines from ICH, USFDA, and EMA.
- Excellent verbal and written communication skills.
- Sharp attention to detail and strong organizational abilities.
Job Location & Salary
- Job Location: Ahmedabad, Gujarat
- Salary: The company offers a competitive salary package that is commensurate with the candidate’s experience and industry standards.
How to Apply for COD Research Careers?
The application process for this Executive role at COD Research is straightforward.
- Prepare your updated resume/CV.
- Send your resume to the official email address: career@cod-research.com.
- Application Deadline: Ensure you apply on or before 10th November 2025.