Regulatory Affairs Drug Manager

Job Role:

• Ensuring that all products meet the regulatory requirements and standards set by health authorities.
• Overseeing the preparation, review, and submission of regulatory documents for new drug applications, clinical trial applications, marketing authorization, and variations to ensure accuracy and completeness.
• Acting as a point of contact for regulatory agencies, maintaining relationships with them, and representing the company in discussions, meetings, and negotiations with these authorities.
• Formulating regulatory strategies for product development and approval, providing input into the planning and execution of these strategies in alignment with business goals.
• Assessing and mitigating risks associated with regulatory compliance, anticipating regulatory obstacles, and devising solutions to ensure timely product approvals.
• Working closely with various departments such as R&D, clinical, quality assurance, legal, and marketing to ensure regulatory considerations are integrated into all aspects of the product life cycle.
• Adherence to Quality Standards.
• Labeling and Packaging Compliance.
• Post-Market Surveillance.