Opening For Regulatory Affairs And IT Department At Remus Pharmaceuticals Ltd

Regulatory Affairs (RA) Department in a pharmaceutical industry is crucial for ensuring that the company complies with all applicable regulations and guidelines during the development, manufacturing, and marketing of pharmaceutical products. This department serves as a bridge between the pharmaceutical company and regulatory authorities.

Roles and Responsibilities of Regulatory Affairs

1. Regulatory Strategy:

   • Develop regulatory strategies for new product development and existing product maintenance.
   • Ensure compliance with global, regional, and local regulatory requirements.

2. Regulatory Submissions:

   • Prepare, compile, and submit dossiers to regulatory agencies for product approval, including:
     • Investigational New Drug (IND) applications.
     • New Drug Applications (NDA).
     • Abbreviated New Drug Applications (ANDA) for generics.
     • Marketing Authorization Applications (MAA) for global markets.
   • Handle post-approval submissions like amendments, supplements, and variations.

3. Liaison with Regulatory Authorities:

   • Communicate with agencies such as the FDA (USA), EMA (Europe), MHRA (UK), CDSCO (India), and others.
   • Respond to agency queries, deficiencies, or inspection findings.

4. Labeling and Advertising Compliance:

   • Review and approve product labels, leaflets, and promotional materials to ensure compliance with regulatory standards.
   • Monitor claims made in advertisements to prevent regulatory issues.

5. Clinical Trial Management:

   • Obtain approvals for clinical trials from regulatory bodies.
   • Ensure trial protocols and reports comply with Good Clinical Practice (GCP) guidelines.

6. Regulatory Intelligence:

   • Stay updated on changing regulatory environments and guidelines.
   • Interpret new regulations and ensure the company adapts accordingly.

7. Documentation and Record Management:

   • Maintain complete and accurate records of all submissions, approvals, and communications with regulatory agencies.
   • Ensure proper archiving for audits or inspections.

8. Product Registration and Renewals:

   • Handle the registration of products in various countries.
   • Manage renewals and maintain compliance with changing regulations.

9. Pharmacovigilance Compliance:

   • Collaborate with the pharmacovigilance team to ensure safety data is submitted as required.
   • Manage periodic safety update reports (PSURs) and adverse event reporting.

10. Regulatory Support for Product Lifecycle:

    • Provide guidance during product development to ensure regulatory compliance.
    • Handle variations, line extensions, and updates for approved products.

11. Audit and Inspection Readiness:

    • Support internal and external audits by regulatory bodies.
    • Ensure the company is always inspection-ready.

Importance of Regulatory Affairs in the Pharmaceutical Industry

• Ensures products meet quality, safety, and efficacy standards set by regulatory agencies.
• Facilitates timely approvals, reducing delays in product launches.
• Helps in avoiding non-compliance issues, which could result in penalties, recalls, or bans.
• Maintains the company’s reputation by ensuring adherence to ethical and regulatory standards.

Remus Pharmaceuticals Ltd.

are hiring for below positions!

Designation: Executive - IT

Exp: 4 to 5 Years into IT infrastructure & IT Compliances in Pharma Industry

Education: Any Graduates / Diploma Holders

Designation: Executive - Regulatory Affairs

Exp: 2 to 3 Years into Regulatory Affairs

Market: ROW

Education: B.Pharm / M.Pharm

Location: Ahmedabad

To Join our Dynamic team, Send your CV on hr@senorespharma.com