Regulatory Affairs Specialist I - Katalyst CRO : Job Details

Join to apply for the Regulatory Affairs Specialist I role at Katalyst CRO

Join to apply for the Regulatory Affairs Specialist I role at Katalyst CRO

• This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files.
• Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.
• Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations.
• Assists in developing regulatory strategies for new and modified products to achieve clearance/approval.
• Research scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy.
• Assesses product, manufacturing, and labeling changes for regulatory impact and compliance.
• Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.

Responsibilities

• This position will have direct responsibility for review and approval of labeling and advertising/promotional materials, approval of global product distribution, and maintenance of regulatory records and files.
• Provides regulatory support for diagnostic product development and commercial products, ensuring compliance with US, EU, and international regulations and standards.
• Reviews and approves labeling, advertising, and promotional materials, and manages translations for country registrations.
• Assists in developing regulatory strategies for new and modified products to achieve clearance/approval.
• Research scientific and regulatory information to develop labeling requirements and reviews verification/validation and risk management reports for accuracy.
• Assesses product, manufacturing, and labeling changes for regulatory impact and compliance.
• Develops internal procedures and tools, and conducts informational or training sessions for stakeholders.

Requirements:

• Bachelor's degree (BS/BA) in any biological science or technical degree.
• 2+ years experience in Regulatory Affairs with 1-3 years of progressively responsible positions.
• Organizes and maintains department files and keeps informed of global regulatory information.
• Demonstrates commitment to the Company Quality Management System per ISO, FDA, and other regulatory agencies.
• Exhibits professional behaviour with internal/external business associates, reflecting positively on the company.
• Understands the quality consequences of improper job performance and is aware of potential device defects in their area of responsibility.

Seniority level

• Seniority levelAssociate

Employment type

• Employment typeContract

Job function

• Job functionLegal
• IndustriesPharmaceutical Manufacturing

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