Senior Regulatory Affairs Specialist

About the role

The Senior Regulatory Affairs Specialist is responsible for ensuring compliance with all relevant regulations and standards. This includes managing regulatory submissions, maintaining documentation, and interacting with regulatory agencies.

Responsibilities

• Manage regulatory submissions for new products and services
• Maintain and update internal regulatory documentation
• Interact with regulatory agencies to address questions and concerns
• Ensure compliance with FDA, EU, and other international regulations
• Support product development teams in understanding and navigating regulatory requirements

Requirements

• Bachelor’s degree in a related field (e.g., Biotechnology, Chemistry, Pharmaceutical Sciences)
• Minimum 5 years of experience in regulatory affairs or a related field
• Experience with FDA and/or EU regulations
• Strong organizational and project management skills
• Excellent written and verbal communication skills

Qualifications

• Knowledge of Good Laboratory Practices (GLP)
• Experience with electronic submission systems (e.g., eCTD)
• Ability to work independently and manage multiple projects simultaneously
• Proficiency in Microsoft Office Suite

Skills

• Strong analytical and problem-solving skills
• Excellent interpersonal and communication skills
• Ability to prioritize tasks and meet deadlines
• Attention to detail and ability to handle confidential information

Benefits

• Competitive salary package
• Flexible working hours
• Professional development opportunities
• Health insurance coverage
• Employee discounts

Pay

• $80,000 - $100,000 annually

Schedule

• Full-time position
• Monday through Friday, 9:00 AM - 5:00 PM