Regulatory Affairs Specialist | Chicago, IL | Onsite

Title: Regulatory Affairs Specialist

Location: Chicago, IL | Onsite

Duration: 09 Months

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

Position Overview

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.

Regulatory Responsibilities:

• 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.

Best regards,

Lavesh Kumar

| Sr. Technical Recruiter

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