Regulatory Strategy Lead – Drug & Device (Contract)

August Bioservices, LLC; Nashville (TN); On-site; USD 85,000 - 110,000; Full time

Job summary

A high-impact contract development organization in Nashville, TN is seeking a Regulatory Manager to develop and implement strategies ensuring compliance with regulations. The ideal candidate will have over 5 years of experience in the biotechnology or pharmaceutical sectors, and a Bachelor’s degree. Responsibilities include managing regulatory submissions, collaborating with teams, and maintaining compliance documentation. Join a dynamic team committed to transforming global health through innovation and compliance.

Qualifications

• 5+ years of experience with regulatory standards in a biotechnology or pharmaceutical environment.
• Proven track record of regulatory strategies and approvals.
• Familiarity with ISO 13485 and US/EU regulations.

Responsibilities

• Develop compliance policies and procedures for regulatory compliance.
• Support regulatory application submissions and communications.
• Ensure internal processes align with regulatory requirements.

Skills

In-depth knowledge of relevant regulations and standards

Experience in developing regulatory compliance documentation

GMP compliance knowledge

Excellent written and verbal communication skills

Education

Bachelor’s degree

Job description

A high-impact contract development organization in Nashville, TN is seeking a Regulatory Manager to develop and implement strategies ensuring compliance with regulations. The ideal candidate will have over 5 years of experience in the biotechnology or pharmaceutical sectors, and a Bachelor’s degree. Responsibilities include managing regulatory submissions, collaborating with teams, and maintaining compliance documentation. Join a dynamic team committed to transforming global health through innovation and compliance.