Regulatory Affairs Manager

Job Description

We are seeking a Regulatory Affairs Manager to oversee compliance with regulatory requirements for our pharmaceutical products. This role demands a thorough understanding of the regulatory landscape and the ability to liaise with multiple stakeholders.

Responsibilities

• Lead the preparation and submission of regulatory documentation, ensuring adherence to industry standards.
• Analyze data from clinical trials to support regulatory submissions.
• Assist in developing strategies for post-market surveillance and reporting issues.
• Establish and maintain effective relationships with regulatory bodies.
• Participate in internal and external audits as needed.

Requirements

Education

• Bachelor's degree in a relevant scientific discipline
• Master's degree in Regulatory Affairs is an advantage

Experience

• At least 5 years of experience in regulatory affairs in a pharmaceutical context

Technical Skills

• Clinical Trials Knowledge
• Quality Assurance

Soft Skills

• Detail-Oriented
• Interpersonal Skills

Certifications

• Certified Clinical Research Associate (CCRA)
• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent

Advantageous

• Experience with EMA regulatory frameworks: Deep knowledge of European Medicines Agency submissions and guidelines.
• Leadership experience: Proven ability to lead teams in regulatory affairs projects.

Benefits

• Health and wellness programs
• Annual performance bonuses
• Professional development opportunities
• Employee assistance programs

Company Culture

• Innovation Driven: We prioritize innovative solutions that enhance patient care and regulatory compliance.
• Employee Support: Our management team offers robust support and resources for all employees.
• Community Engagement: We are actively involved in community initiatives and encourage volunteerism amongst staff.