August Bioservices, LLC · 1 day ago
Manager, Regulatory Affairs
Nashville, TN
Contract
Onsite
Mid, Senior Level
5+ years expAugust Bioservices is a privately-owned Contract Development Manufacturing Organization based in Nashville, TN. The Regulatory Manager develops and implements regulatory strategies to ensure pharmaceutical products comply with government regulations and industry standards throughout their lifecycle.
BiotechnologyMedicalPharmaceutical
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
Qualification
Required
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
Preferred
Professional certifications in regulatory affairs are a plus
Company
August Bioservices, LLC
August Bioservices, a leading sterile injectable CDMO headquartered in Nashville, Tennessee, delivers end-to-end contract development and manufacturing services for pharmaceutical and biotech clients.
51-200 employees
H1B Sponsorship
August Bioservices, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (11)
2023 (12)
2022 (2)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$88.6MKey Investors
Oak HC/FTPolaris Partners
2022-12-01Series B· $65M
2021-05-27Series A· $23.6M
2020-07-16Series Unknown
Leadership Team
Mats Bjoerkman
Chief Financial Officer
Colette Lanzon
Talent Acquisition Business Partner
Recent News
Seattle TechFlash
2025-06-24
The Business Journals
2024-02-11
Company data provided by crunchbase