Manager, Regulatory Affairs

August Bioservices • Nashville, TN

2d

About The Position

The Regulatory Manager develops and implements regulatory strategies to ensure pharmaceutical products comply with complex government regulations and industry standards throughout their lifecycle, from development to market approval and post-market activities. Key responsibilities include supporting customers to prepare and submit regulatory applications, communicating with health authorities, ensuring compliance of labeling, and staying informed about evolving legislation. This role requires strong collaboration with cross-functional teams like R&D, production, and customers, and involves managing documentation, risk assessment, and providing strategic regulatory guidance. The regulatory manager should have experience with combination products. The manager develops and executes regulatory strategies for drug-device products, ensures compliance with global health authority regulations, and leads cross-functional teams to support submissions for our customers.

Requirements

• Bachelor’s degree and > 5 years of experience Regulatory standards within a biotechnology, biologics, or pharmaceutical or medical device manufacturing facility. Good understanding of ISO 13485 and EU and US medical device regulations
• Proven track record of successfully developing and executing regulatory strategies and obtaining regulatory approvals for products.
• In-depth knowledge of relevant regulations and standards, such as FDA regulations, ISO standards, and other applicable regional regulations.
• Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation
• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing and Part 11 compliance knowledge.
• Develop and implement regulatory strategies for medical devices, ensuring global compliance with specific regulations like the EU MDR and FDA requirements.
• Lead the maintenance and advancement of the Quality Management System (QMS) to ensure ongoing certification to ISO 13485
• Dynamic, self-motivated, pro-active approach to taking on challenging assignments
• Excellent written and verbal communication skills in English, with the ability to adapt communication styles to different audiences.

Nice To Haves

• Professional certifications in regulatory affairs are a plus

Responsibilities

• Ensures that products and internal processes comply with laws and regulations by developing compliance policies, operational procedures, and standard operating procedures (SOPs).
• Works closely with R&D, Quality Assurance, Production, Marketing, and other departments to ensure alignment with regulatory requirements.
• Stays abreast of changes in regulatory legislation, guidelines, and industry trends to identify potential impacts on the company and its products
• Provides guidance to ensure that all product labeling, packaging, and customer requirements materials comply with regulatory standards
• Support quality assurance for risk assessments, facilitates regulatory audits and inspections, and addresses any findings promptly.
• Improve internal processes to reduce risk
• Supervise the maintenance of regulatory databases (Client product registration information, components).
• Provide regulatory guidance (strategy definition, requirements assessment).
• Curiosity to learn about our products, their applications, and how to apply regulatory requirements to our portfolio

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 101-250 employees