Manager, Regulatory Affairs
August Bioservices
Legal
Nashville, TN, USA
Posted on Jan 7, 2026
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.
ESSENTIAL DUTIES & 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
QUALIFICATIONS
- 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.
- Professional certifications in regulatory affairs are a plus
KNOWLEDGE, SKILLS, & ABILITIES
- 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.
PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
· Prolonged periods sitting at a desk and working on a computer.
· Must be able to lift up to 25 pounds at times.
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.