Regulatory and Compliance Manager

The Regulatory Affairs and Compliance Manager is responsible for leading and overseeing the companys regulatory and compliance activities. This role ensures that products meet all applicable legal, safety, quality, and environmental standards. The manager will foster a culture of compliance across the organization, support external and internal audits, and collaborate with cross-functional teams to align compliance strategies with business objectives.

Key Responsibilities

• Lead, coach, and motivate team members to achieve compliance and regulatory objectives.
• Develop and implement compliance strategies to ensure products meet all regulatory requirements.
• Conduct risk assessments on new products and product changes; develop mitigation plans as needed.
• Monitor and interpret local, national, and international regulatory updates and ensure timely implementation.
• Prepare and submit compliance reports to management and relevant regulatory authorities.
• Manage relationships with regulatory authorities, certification bodies, testing laboratories, and service providers.
• Oversee internal audits, inspections, and gap analyses to ensure compliance with laws and standards.
• Support external audits and inspections by regulatory agencies.
• Provide compliance training and education programs for employees.
• Evaluate and monitor suppliers and vendors for adherence to company and regulatory requirements.
• Maintain accurate and up-to-date databases of compliance documentation and activities.
• Collaborate with cross-functional teams, including Legal, Import, and HQ Compliance teams, to ensure alignment of compliance goals.
• Review service provider invoices for completeness and alignment with contracts/agreements.
• Provide expert regulatory and compliance advisory support to stakeholders across the business.
• Perform other job-related tasks as assigned.

Qualifications & Requirements

• Bachelors degree in Pharmacy or a related field.
• Minimum of 8 years relevant experience in regulatory affairs and compliance.
• Proficient in stakeholder management, with the ability to build and maintain strong relationships with internal and external stakeholders to ensure alignment and compliance.
• Detail-oriented approach, committed to accuracy and thoroughness in all compliance-related activities.

• Demonstrated expertise in regulatory compliance roles within similar industries, with a comprehensive understanding of relevant regulations and standards.
• Strong project management abilities, including organizing, prioritizing, multitasking, managing deadlines, and coordinating cross-functional teams.
• Excellent communication skills (both verbal and written), capable of conveying technical information clearly and concisely to diverse audiences.
• Effective leadership skills, with the ability to motivate teams and achieve objectives.

• Strong analytical, critical thinking, and problem-solving abilities.
• Experience in people management.