Regulatory Affairs Associate II

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

Target PR Range: 29-39/hr

Depending on experience

• Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management
• Preferred Experience: 6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
• Experience working in a complex and matrix environment
• Strong oral and written communication skills

This contractor will work with internal and external partners in order to deliver products to patients. Job deliverables will include:

• Prepare regulatory submissions, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and responds to regulatory information.
• Analyzes and interprets information that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions
• Manages preparation for agency meetings and manages content of pre-meeting submissions.
• Manages products and change control with an understanding of regulations and company policies and procedures.

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 3 to 5 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected.

Experience Level = 3-5 Years