Job Responsibilities
As a CDSCO Regulatory Affairs Specialist, your key responsibilities will include:
- Managing CDSCO regulatory submissions for medical devices and cosmetics.
- Preparing and reviewing dossiers for registration and import licenses.
- Ensuring compliance with pharmaceutical regulations and EudraLex guidelines.
- Handling regulatory intelligence and change management processes.
- Managing product lifecycle activities, including amendments and renewals.
- Utilizing the Sugam Portal for regulatory submissions and approvals.
- Obtaining and maintaining various licenses such as COS-2, COS-4, MD-15, MD-5, MD-9.
- Submitting applications for new drug, medical device, and diagnostic kit registrations.
- Liaising with CDSCO/DCGI for application follow-ups and deficiency letter resolutions.
- Ensuring adherence to Good Manufacturing Practices (GMP) and quality management systems.
Qualifications
To be eligible for this role, candidates must meet the following criteria:
- Education: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
- Experience: Minimum 1+ years in regulatory affairs for cosmetics or medical devices.
- Strong understanding of CDSCO regulations, especially related to the Sugam Portal.
- Familiarity with dossier preparation, submission requirements, and regulatory approvals.
- Experience in handling import licenses, manufacturing licenses, and test licenses.
- Ability to analyze and interpret complex regulatory guidelines and quality management standards.
Key Skills Required
Candidates should possess the following skills to excel in this role:
- Regulatory compliance knowledge related to CDSCO and pharmaceutical regulations.
- Dossier preparation expertise for medical devices and cosmetics.
- Proficiency in using the Sugam Portal for submissions and tracking approvals.
- Project management skills to handle multiple regulatory tasks efficiently.
- Strong communication and interpersonal skills for coordination with regulatory authorities.
- Attention to detail to ensure accurate submissions and compliance with industry standards.
- Problem-solving ability to address regulatory challenges and resolve queries promptly.
- Adaptability to evolving regulatory requirements and deadlines.
How to Apply
Advertisement
If you meet the eligibility criteria and are interested in joining our regulatory affairs team, apply now by following these steps:
- Submit your resume and cover letter detailing your relevant experience and qualifications.
- Email your application to hr@jrcompliance.com with the subject line Application for CDSCO Regulatory Affairs Specialist.
