Regulatory Affairs

Farbe Firma Pvt. Ltd.; Ankleshwar; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Farbe Firma Pvt. Ltd. in India seeks an experienced regulatory affairs professional to lead regulatory strategy and ensure compliance across global markets.

You will prepare registration dossiers, monitor evolving requirements (US FDA, EU, India) and interact with regulatory agencies. You will also contribute to ongoing regulatory quality systems and audits, and ensure meticulous documentation and clear communication.

Qualifications

• Bachelor's in Pharmacy or Life Sciences required.
• 5+ years regulatory experience.
• Experience with dossier preparation and submissions.
• Knowledge of global regulatory requirements (US FDA, EU, India).
• Strong communication and documentation skills.
• Experience with regulatory quality systems and audits.

Responsibilities

• Manage regulatory strategy and compliance.
• Prepare registration dossiers.
• Monitor regulatory requirements globally.
• Interact with regulatory agencies.
• Ensure adherence to standards.

Skills

Regulatory strategy

Regulatory compliance

Regulatory submissions

Global regulations

Documentation

Quality audits

Education

Bachelor's in Pharmacy/Life Sciences

Job description

Manage regulatory strategy and compliance. Prepare registration dossiers. Monitor regulatory requirements globally. Interact with regulatory agencies. Ensure adherence to standards.

Requirements

Bachelor's in Pharmacy/Life Sciences with 5+ years regulatory experience

Expertise in global regulatory requirements (US FDA, EU, India)

Knowledge of dossier preparation and submissions

Strong communication and documentation skills

Experience with regulatory quality systems and audits