Regulatory Affairs Manager

Job Description

We are seeking a Regulatory Affairs Manager who will lead and manage compliance activities, ensuring our pharmaceutical products meet stringent regulatory standards. The ideal candidate will have extensive experience in navigating FDA, TGA, and EU regulations, while supporting our R&D and commercial teams.

Responsibilities

• Develop regulatory submission strategies and delivery timelines.
• Conduct thorough reviews of regulatory documents and submissions.
• Collaborate with legal and quality teams to ensure compliance.
• Prepare reports on regulatory assessments and status updates.
• Train and mentor junior regulatory staff in best practices.
• Engage with cross-functional teams to support product lifecycle management.
• Identify risks and propose mitigation strategies for regulatory compliance.
• Liaise with external consultants for specialized regulatory advice.

Requirements

Education

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

Experience

• Minimum of 10 years of regulatory affairs experience within the pharmaceutical or biotechnology industry.

Technical Skills

• Regulatory Strategy Development
• Submission Management
• FDA Regulations Knowledge
• Project Management

Soft Skills

• Leadership
• Communication
• Analytical Thinking

Certifications

• Certified Regulatory Affairs Professional (CRAP)
• Regulatory Affairs Certification (RAC)

Languages

• English: Fluent

Advantageous

• Experience with Rare Diseases: Desirable experience with regulatory submissions for orphan drugs.
• Familiarity with Digital Healthcare Products: Knowledge of compliance related to digital health technologies.

Benefits

• Comprehensive health and wellness programs
• Professional training and education support
• Team-building activities and events
• Access to mental health resources

Company Culture

• Collaboration: We are a cohesive team that thrives on collaboration and open communication.
• Innovation: Creativity and innovation are encouraged, leading to groundbreaking outcomes.
• Inclusivity: We value diversity and inclusiveness in our workplace culture.