Regulatory Affairs Consultant

Job Description

We are on the hunt for a knowledgeable Regulatory Affairs Consultant to strengthen our compliance team. This role will involve the preparation and submission of regulatory documents, liaising with health authorities, and maintaining up-to-date knowledge of regulatory guidelines.

Responsibilities

• Develop regulatory strategies to ensure timely approval of products.
• Lead projects related to regulatory submissions and compliance.
• Advise on the regulatory implications of product changes.
• Review and assess clinical trial protocols for regulatory compliance.
• Coordinate with external consultants and stakeholders as necessary.

Requirements

Education

• Bachelor's degree in Pharmacy or similar field
• Advanced degree preferred

Experience

• 5+ years of experience in regulatory affairs, with experience in clinical trials advantageous

Technical Skills

• Regulatory Submissions
• Compliance Management

Soft Skills

• Interpersonal Skills
• Organisational Skills

Certifications

• Certified Clinical Research Associate (CCRA)

Languages

• English: Fluent

Advantageous

• Experience in advising on product labelling: Knowledge of labelling rules and requirements across different markets.
• Familiarity with Risk Management strategies: Experience in implementing risk management tools and approaches.

Benefits

• Salary reviews and incentives
• Comprehensive health insurance plan
• Work-life balance initiatives
• Support for continuous education

Company Culture

• Diversity and Inclusion: We are committed to creating a diverse and inclusive workplace, ensuring that all voices are welcomed and valued.
• Employee Wellbeing: We prioritize the wellbeing of our employees, offering various programs and initiatives to support mental health and work-life balance.