Regulatory Manager

Job Description

Overview
We are seeking a dedicated and experienced Regulatory Manager to join our dynamic team. The ideal candidate will play a crucial role in ensuring compliance with regulatory requirements across our operations. This position requires a strategic thinker with a strong understanding of regulations relevant to our industry, capable of managing multiple projects while fostering relationships with regulatory bodies.

Responsibilities

• Develop, implement, and maintain regulatory strategies to ensure compliance with local, national, and international regulations.
• Monitor and interpret regulatory developments and assess their impact on the organization.
• Prepare and submit regulatory filings and documentation to relevant authorities in a timely manner.
• Collaborate with cross-functional teams to integrate regulatory requirements into business practices and product development.
• Conduct internal audits and assessments to ensure adherence to regulatory standards and identify areas for improvement.
• Provide training and guidance to staff on regulatory compliance and best practices.
• Liaise with external regulatory bodies, industry groups, and stakeholders to represent the organization and advocate for its interests.
• Prepare comprehensive reports and presentations for senior management regarding compliance status and regulatory changes.

Requirements

• Proven experience as a Regulatory Manager or similar role within a related industry.
• In-depth knowledge of regulatory frameworks and compliance standards.
• Strong analytical skills with an ability to interpret complex regulations and assess their implications.
• Excellent communication and interpersonal skills to effectively collaborate with internal teams and external stakeholders.
• Strong project management skills with the ability to manage multiple priorities and deadlines.
• Proficiency in regulatory submission processes and documentation.

Qualifications

• Bachelor’s degree in a relevant field such as Law, Life Sciences, or Business Administration; Master’s degree preferred.
• Professional certification in regulatory affairs (e.g., RAC) is a plus.
• Minimum of 5 years of experience in regulatory management or compliance roles.
• Familiarity with industry-specific regulations and standards (e.g., FDA, EMA, ISO).
• Strong attention to detail and ability to work independently and as part of a team.

We invite qualified candidates to apply and become part of our commitment to excellence in regulatory compliance and management.