In the dynamic world of pharmaceuticals, regulatory affairs play a pivotal role in ensuring the safety and efficacy of drug products before they reach consumers. At Cadila Pharmaceuticals Ltd., we’re on the lookout for skilled professionals to join our team, specifically for the position of Regulatory Affairs with a focus on the US market. If you are passionate about compliance and possess significant expertise in this field, you might be the perfect fit for our organization.
Job Role: Regulatory Affairs (US Market)
Location: Dholka, Ahmedabad, Gujarat
Experience Required: Minimum 6 Years
Key Responsibilities
As a Regulatory Affairs professional at Cadila Pharmaceuticals, you will have various critical tasks aimed at ensuring our products meet the stringent regulations of the US market. Your key deliverables will include:
- Compilation, Review, and Submission of Registration Dossiers: You will be responsible for preparing and submitting comprehensive registration dossiers to regulatory bodies in the US, ensuring that all documents are accurate, complete, and in compliance with US regulations.
- Handling Regulatory Queries/Deficiencies: The ability to respond to regulatory queries and rectify any deficiencies promptly will be crucial in maintaining our licenses and ensuring uninterrupted market access.
- Post-Approval Activities: This includes reviewing annual reports and managing post-approval supplements such as CBE-0, CBE-30, and PAS submissions, thus maintaining compliance throughout the product lifecycle.
- eCTD Software Management: Familiarity with eCTD (Electronic Common Technical Document) software is essential for effective ANDA (Abbreviated New Drug Application)/IND (Investigational New Drug) submissions and query responses.
- Reviewing Functional Documents: You will review and approve various documents, including Specifications, Test Procedures, Stability Protocols, and more, ensuring they meet the required regulatory standards.
- Analytical Method Validation: Your expertise will also extend to overseeing analytical method validation, verification, and transfer reports to ensure testing integrity.
- DMF Reviews: Regular review of Drug Master Files (DMF) and its notifications will be among your critical responsibilities.
- Change Controls & Deviations Approval: It is vital to ensure that any changes to the manufacturing process are properly documented and approved under regulatory guidelines.
- Creation and Maintenance of Regulatory Database: You will maintain a comprehensive regulatory database for all submissions, ensuring easy access and traceability.
- Tracking Regulatory Guidance Documents: Keeping up-to-date with the latest regulatory guidance documents on relevant websites is essential for compliance.
- Training Across the Team: You will also play a crucial role in imparting training to team members on new guidance documents and regulatory updates.
Why Work with Us?
Cadila Pharmaceuticals is one of the leading companies in the pharmaceutical industry, recognized for our commitment to quality, innovation, and patient safety. By joining our team, you will not only advance your career in regulatory affairs but also contribute to the global healthcare landscape while working within a supportive and collaborative environment.
How to Apply
If you are an experienced Regulatory Affairs professional looking for an exciting opportunity to make a difference in the pharmaceutical industry, we would love to hear from you. Interested candidates are encouraged to share their CVs with us at disha.bhalani@cadilapharma.com.
Conclusion
This is a fantastic opportunity for professionals with a strong background in regulatory affairs and a desire to work in a fast-paced environment. If you meet the qualifications and are ready to take on the challenges of this vital role, don’t hesitate to apply today! At Cadila Pharmaceuticals, we value your expertise and look forward to potentially welcoming you to our team.
