Regulatory Affairs Director

Job Description

We are seeking a skilled Regulatory Affairs Director to lead compliance initiatives and ensure adherence to laws and regulations. The ideal candidate will possess a deep understanding of regulatory frameworks and have a proven track record in navigating compliance challenges.

Responsibilities

• Oversee the review and approval of product labeling and advertising for compliance.
• Assist with regulatory audits and inspections, preparing necessary documentation.
• Maintain knowledge of industry standards and best practices related to regulatory affairs.
• Provide expert guidance on compliance matters to senior leadership.
• Support the development and execution of global regulatory strategies.
• Contribute to the continuous improvement of compliance processes.

Requirements

Education

• Bachelor's degree in Life Sciences or related field
• Master's degree preferred

Experience

• 7+ years of experience in regulatory affairs or compliance roles

Technical Skills

• Regulatory Strategy Development
• Risk Management

Soft Skills

• Leadership Skills
• Negotiation Skills

Certifications

• Regulatory Affairs Certification (RAC)
• Certified Compliance and Ethics Professional (CCEP)

Languages

• English: Fluent

Advantageous

• Experience in change management: Skilled in managing transitions within regulatory frameworks.
• Familiarity with electronic submission systems: Experience with platforms for regulatory submissions and communications.

Benefits

• Attractive salary package
• Comprehensive health coverage
• Generous retirement contributions
• Work-from-home options

Company Culture

• Professional Development: We are committed to providing opportunities for continuous learning and advancement.
• Diversity and Inclusion: Our team thrives on diversity and is dedicated to creating an inclusive workplace.
• Wellness and Work-Life Balance: We support our employees' health and well-being through flexible working policies.