Ciron Drugs & Pharmaceuticals Pvt. Ltd., a prominent WHO GMP and ISO 9001:2008 certified pharmaceutical manufacturer, is actively seeking talented professionals to join their Regulatory Affairs team in Mumbai Metropolitan Region. This role presents an exciting opportunity to work in a dynamic environment focused on delivering high-quality pharmaceutical products.

Company Introduction

Ciron Drugs & Pharmaceuticals Pvt. Ltd. has established itself as a trusted name in the pharmaceutical industry. With state-of-the-art manufacturing facilities at Tarapur and Palghar, the company specializes in producing pharmaceutical formulations in multiple forms. Its commitment to quality and compliance has earned it a strong reputation in the global market, particularly in the US and EU.

Responsibilities in the Job

As a Regulatory Affairs Officer, your key responsibilities will include:

1. Dossier Preparation and Submission: Compiling and submitting registration dossiers in eCTD format for the US and EU markets.
2. Document Management: Ensuring accurate processing of documents (PDF) and handling PASS, CBE-0, CBE-30 applications for the US, and post-approval applications for the EU.
3. Cross-Department Coordination: Collaborating with Plant, R&D, CQA, and ADL departments for technical documentation and ensuring alignment with ICH or country-specific requirements.
4. Quality and Timeliness: Reviewing and compiling Quality documents (Modules 2 & 3) to meet stipulated timelines and quality standards.
5. Artwork Review: Checking and approving artworks as per country-specific regulations.
6. Agency Communication: Liaising with agents to track the progress of registration submissions and maintain records for dossiers and sample submissions.
7. Registration Management: Maintaining and updating country-wise registration statuses and arranging renewals.
8. Query Resolution: Preparing accurate and timely responses to regulatory agencies’ queries.
9. Marketing Liaison: Collaborating with the marketing team to finalize product pipelines and provide necessary dossiers for submissions.

Qualifications

• A Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related field.
• Experience: 2–3 years of regulatory affairs experience, specifically in the US and EU markets.

Skills Required

1. In-depth knowledge of eCTD format submissions.
2. Expertise in PASS, CBE-0, CBE-30, and post-approval applications.
3. Familiarity with ICH guidelines and country-specific regulatory requirements.
4. Strong document management and quality assurance skills.
5. Excellent communication and coordination abilities.

Application Link