Ciron Drugs & Pharmaceuticals Pvt. Ltd. is a renowned pharmaceutical company with a legacy of excellence. Based in the Mumbai Metropolitan Region, the company operates WHO-GMP and ISO 9001:2008-certified manufacturing plants located in Tarapur and Palghar. With a strong commitment to producing high-quality pharmaceutical formulations in various forms, Ciron Drugs caters to diverse markets, ensuring safety, efficacy, and compliance with global standards.
Job Responsibilities
As a Regulatory Affairs Officer, you will play a pivotal role in ensuring regulatory compliance for the company’s products in the US and EU markets. Key responsibilities include:
- Preparing and submitting registration dossiers in eCTD format for US and EU markets.
- Processing and reviewing technical documents (PDF) for regulatory submissions.
- Managing applications such as PASS, CBE-0, CBE-30 for the US and post-approval applications for the EU.
- Coordinating with the Plant, R&D, CQA, and ADL departments to gather and verify documents as per ICH or country-specific requirements.
- Ensuring quality standards and adherence to submission timelines.
- Compiling and reviewing quality documents, particularly Modules 2 and 3.
- Checking and approving artworks based on country-specific requirements.
- Communicating with agents to track registration submission progress.
- Maintaining detailed records of dossiers, sample submissions, and country-wise registration statuses.
- Managing dossier renewals and updating submission statuses.
- Collaborating with the marketing team to finalize product pipelines and ensure timely dossier submissions.
- Responding promptly and accurately to regulatory agency queries.
Qualifications
- A minimum of 2 to 3 years of experience in regulatory affairs, specifically in the US and EU markets.
- Familiarity with eCTD dossier preparation and submission processes.
- Strong knowledge of ICH guidelines and country-specific regulatory requirements.
Skills
- Excellent understanding of pharmaceutical regulatory processes.
- Proficiency in technical document review and processing.
- Attention to detail and ability to ensure compliance with quality standards.
- Effective communication and coordination skills.
- Ability to manage multiple projects and meet deadlines
