Job Description

Job Description

Regulatory Affairs Manager - Biologics

Job Purpose

** MUST HAVE BIOLOGICS EXPERIENCE **

LOCATION: On-site in Lenoir, NC

** Will assist in relocation **

The Americas Regulatory Affairs Manager is responsible for overseeing and managing the routine operations of the regulatory affairs department. In this role, the Manager ensures compliance with applicable regulatory requirements, including those from the US FDA, Health Canada, USDA, and other applicable regulatory agencies, while providing regulatory strategy and support across the business.

Major Accountabilities

• Oversee and manage all Regulatory Affairs activities to ensure the technical accuracy, quality, content and format of all regulatory submissions in the appropriate format (eCTD) to the FDA, Health Canada, USDA, and other regulatory agencies.
• Lead the preparation, submission and management of regulatory filings such as INDs, BLAs, 510(k)s and/or other market authorization applications for both existing and new products.
• Assess and address regulatory impact of product and manufacturing changes, including overseeing change control assessments.
• Plan, coordinate and participate in formal meetings, teleconferences, and written communication with regulatory agencies, ensuring timely responses to requests.
• Oversee the preparation, review, and submission of all biologic and veterinary prescribing information and product labeling, ensuring compliance with all regulatory requirements.
• Review and approve promotional and advertising materials, ensuring adherence to applicable laws, regulations, and company policies, including timely submission of materials to regulatory agencies.
• Provide regulatory strategy guidance to project teams and other departments to support product development and life cycle management.

Professional Experience/Qualifications

• 5+ years of related regulatory experience in the biologics and medical device areas.
• Regulatory Affairs Certification (RAC) is preferred.
• Thorough understanding of the laws and regulations for the US FDA, Health Canada, USDA, ICH Guidelines, and any other applicable Agency.

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