Regulatory Affairs Specialist

Job Description

As a Regulatory Affairs Specialist in our organization, you will be responsible for preparing regulatory submissions, liaising with health authorities, and maintaining compliance throughout the product lifecycle. We are looking for someone who is detail-oriented and passionate about regulatory processes.

Responsibilities

• Gather and prepare documentation for product registration applications.
• Review labeling and promotional materials for compliance with legal requirements.
• Participate in audits and inspections by regulatory authorities.
• Support the preparation of dossier submissions for international markets.
• Develop and maintain regulatory submission timelines.
• Collaborate with R&D to ensure alignment of regulatory requirements with product development.

Requirements

Education

• Bachelor's degree in Regulatory Affairs or a related discipline
• Master's or higher qualification in a relevant field is preferred

Experience

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

Technical Skills

• Regulatory Submissions
• Clinical Development Knowledge

Soft Skills

• Project Management
• Problem-solving

Certifications

• Certified Manager of Regulatory Affairs

Languages

• English: Fluent

Advantageous

• Project Management Professional (PMP) certification: Credential that demonstrates expertise in project management.
• Proficiency in regulatory software tools: Experience with software that assists in regulatory submissions and compliance tracking.

Benefits

• Comprehensive health insurance coverage
• Retirement savings plan with employer match
• Flexible work schedule with remote options
• Ongoing training and education support

Company Culture

• Commitment to Quality: Quality is at the heart of our operations, and we strive for excellence in everything we do.
• Employee Wellbeing: We are committed to the wellbeing of our employees, providing resources and support to help them succeed.
• Professional Growth: We support ongoing professional growth and encourage employees to take on new challenges.