Executive Regulatory Affairs

Responsibilities for regulatory affairs

• Be a key point of contact for Russia & CIS (in CIS via distributors)
• Regulatory due diligence including evaluation and review of documentation for compliance with approved authorisations
• Preparation of monthly metrics and reports to monitor and cross-compare the quality systems
• Work as a team member in developing the regulatory oversight of CMOs
• Participate in regular team and group meetings ensuring to keep the management team updated on issues and actions which impact the business
• Ensuring the effective implementation of a quality management system in the Regulatory function
• Be flexible within the Regulatory function to meet the needs of the growing business
• Perform general duties as required by the Regulatory Manager
• Active participation and timely delivery results in RA teams to achieve common goals or attend common strategies
• Supervises the work of translation and dossier contractor with the help of Sr

Qualifications for regulatory affairs

• Bachelor’s degree in Life Sciences, Chemistry, Molecular Biology or similar discipline required
• Ability and desire to progress and represent Acorn Regulatory in an exemplary manner
• As Regulatory Affairs Professional you will be working with development and maintenance/ of the CMC documentation for products (Drug Substances and Drug Products)
• You will perform regulatory assessment of change control cases
• You will prepare regulatory strategies and participate in the preparation of the quality documentation to support clinical trial applications (INDs, IMPDs), new marketing authorisations (NDAs, MAAs) and variation applications in global markets
• In close cooperation with other Regulatory Affairs colleagues, you will plan and project-manage CMC related aspects regarding submissions

Job Types: Full-time, Permanent

Pay: ₹25,342.09 - ₹40,024.47 per month

Benefits:

• Health insurance
• Paid sick time
• Provident Fund

Work Location: In person