Biotech Jobs North Carolina | Senior Director, Regulatory @ KBI Biopharma, North Carolina: We are a biopharma contract development & manufacturing organization driven to improve the quality of human life – we do this by serving our clients in the accelerated development of their needed medicines. To date, we’ve served over 200 clients around the world. We help our client partners accelerate and optimize drug development and manufacturing programs by offering an extensive suite of expert development and manufacturing services in an agile, client-friendly partnering environment. Clients include global pharmaceutical and biotechnology companies and academic/non-profit organizations. Today we serve more than 200 clients in the US, Canada, Europe, Korea and Japan, including most of the top ten pharmaceutical companies. KBI was founded in 1996 and is based in Durham, North Carolina, near Research Triangle Park (RTP).
Biotech Jobs North Carolina | Senior Director, Regulatory @ KBI Biopharma, North Carolina
DUTIES AND JOB FUNCTIONS:
- Lead CMC writing and review for Sponsors, utilize internal resources as needed to draft, review and edit CMC sections of Sponsor’s filings.
- Provide overall direction to Regulatory department that is responsible for CMC support, regulatory inspection support, updating site files and registrations
- Interact with clients on Regulatory topics.
- Communicate with regulatory agencies regarding regulatory matters for KBI Biopharma.
- Responsible for assuring that departmental employees comply with required procedures, meet training requirements and participate in safety training.
- Bachelor degree in pharmaceutical science, biology, biochemistry, or related science.
- 10-years work experience in development of biologics pharmaceuticals, (Research and Development experience helpful); with at least 3 years of supervisory experience.
- Requires thorough knowledge of regulatory guidelines as they relate to development of cell culture based or fermentation based biopharmaceutical products.
- Experience with FDA, EMA and knowledge of regulatory requirements with emphasis on regulatory requirements for biotechnology-derived products.
- Ph.D. in relevant scientific discipline preferred
- Prior extensive technical (analytical or manufacturing process) experience with protein therapeutics, prior experience in authoring and reviewing technical accuracy of CMC documents for protein therapeutics.
- Regulatory support and health authority inspection experience.
- Prior contract manufacturing experience preferred.
- Strong orientation for regulatory compliance and Customer Service
- Excellent writing and verbal communication skills
- Demonstrated level of respect for individuals
- Demonstrated contribution to science in appropriate area
- High level of integrity and personal responsibility
- Record of innovation
- Strong collaboration and team building skills
KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or Vietnam veteran status, are strongly encouraged to apply.
Biotech Jobs North Carolina | Senior Director, Regulatory @ KBI Biopharma, North CarolinaApply Now
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