Biomanufacturing Regulatory Affairs Specialist

San Antonio, Texas


Employer: Insight Global
Industry: QA
Salary: $90 - $120000. per year
Job type: Full-Time

A company based in San Antonio; TX is seeking a Regulatory Affairs Specialist to join their team. The role involves overseeing the Regulatory Affairs aspect of the team's activities, ensuring adherence to compliance throughout the biomanufacturing process. This role will be instrumental in identifying areas for continuous process improvement, ensuring compliance with different regulation agencies. Salary for this position ranges from $90-$120,000.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience
- Bachelor's degree in applied science
- A minimum of 5 years of supporting regulatory agencies such as the FDA, EU, and ISO
- Experience with regulatory compliance and quality assurance within biomanufacturing

Nice to Have Skills & Experience
- Master's degree
- Aseptic Biologics, clean room experience
- Master Control Experience

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.

Created: 2024-06-20
Reference: 346775
Country: United States
State: Texas
City: San Antonio
ZIP: 78112


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