Regulatory Affairs Associate II: PMA & Med Devices

Planet Pharma; North Chicago (IL); On-site; USD 40,000 - 54,000; Part time

Job summary

Planet Pharma is seeking a contractor with strong regulatory affairs experience to deliver regulatory submissions and manage agency interactions. The role emphasizes quality systems and cross-functional project management in a matrix environment.

The candidate should have a Bachelor's degree in a related field and 6 years of pharmaceutical experience, including experience with PMA-style processes and Class III devices. Excellent communication skills are essential for success in this role.

Qualifications

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• 6 years pharmaceutical or industry related experience.
• 3-5 years in quality systems or cross-functional project management.
• Experience in regulatory affairs or related fields is preferred.
• Excellent written and oral communication skills.

Responsibilities

• Prepare regulatory submissions and amendments, renewals, annual reports and variations.
• Analyze information impacting regulatory decisions and seek expert advice as needed.
• Manage preparation for agency meetings and content of pre-meeting submissions.
• Oversee product changes and change control in line with regulations and company policies.

Skills

Regulatory affairs

Quality systems

Cross-functional PM

Regulatory submissions

Communication

Education

Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

Job description

Planet Pharma is seeking a contractor with strong regulatory affairs experience to deliver regulatory submissions and manage agency interactions. The role emphasizes quality systems and cross-functional project management in a matrix environment.

The candidate should have a Bachelor's degree in a related field and 6 years of pharmaceutical experience, including experience with PMA-style processes and Class III devices. Excellent communication skills are essential for success in this role.