Manager, Regulatory Affairs

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry.

Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state‑of‑the‑art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

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.

• 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.

• Bachelor’s degree and > 5 years of experience in 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.
• Professional certifications in regulatory affairs are a plus.

• 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 21
  
  CFR
  210, 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…