CMC Director, Regulatory Affairs

About the role

The successful candidate will lead the regulatory affairs function, ensuring compliance with all relevant regulations and guidelines.

Responsibilities

• Oversee the development and implementation of regulatory strategies for new products.
• Manage interactions with regulatory bodies and ensure timely submission of required documents.
• Ensure compliance with all applicable regulations and maintain regulatory documentation.
• Collaborate with cross-functional teams to develop and implement regulatory strategies.

Requirements

• A minimum of 10 years of experience in regulatory affairs or related field.
• Proven track record in leading regulatory strategy development and execution.
• Experience working with FDA, EMA, and other global regulatory bodies.
• Strong understanding of pharmaceutical and medical device regulations.
• Excellent communication and interpersonal skills.

Qualifications

• Master’s degree in a relevant field such as pharmacology, medicine, or a related discipline.
• Pharmaceutical industry experience preferred.

Skills

• Strong leadership and project management skills.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple projects simultaneously.

Benefits

• Competitive salary package.
• Flexible working hours.
• Professional development opportunities.

Pay

• $100,000 - $120,000 annually.

Schedule

• Full-time position.

Contact

To apply, please fill out the form below. We look forward to hearing from you!