Company Description

DDReg Pharma Pvt. Ltd. is a global partner in the life sciences industry, offering specialized consulting services in Regulatory Affairs, Pharmacovigilance, Quality, IPR, GMP Compliance, and Toxicology. With extensive experience, we support pharmaceutical and biopharma companies in expediting product registrations and maintaining regulatory compliance throughout the product lifecycle. Leveraging cutting-edge in-house tools such as our AI-driven Regulatory Intelligence Platform and Regulatory Information Management System (RIMS), we enable efficient and compliant operations. Our mission is to drive smarter and faster processes for achieving regulatory success.

Role Description

This is a full-time, on-site role for Assistant Manager - Regulatory Affairs - Emerging Markets, located in Gurugram. The role involves managing regulatory submissions and ensuring compliance with local and international regulatory requirements. The candidate will handle documentation, coordinate with internal and external stakeholders for regulatory activities, and address regulatory deficiencies. Additional responsibilities include supporting the development of regulatory strategies to facilitate product approvals and maintaining quality systems to adhere to industry standards.

Qualifications

• Sound knowledge and experience in Regulatory Affairs, including regulatory submissions and managing regulatory compliance.
• Familiarity with Regulatory Requirements and the ability to navigate regulations for different markets.
• Proficiency in maintaining and enhancing Quality Systems to meet industry standards and compliance expectations.
• Strong coordination and communication skills to engage with cross-functional teams and external regulatory agencies effectively.
• A degree in Pharmacy, Life Sciences, or related fields, with experience in the pharmaceutical or biopharma industry.