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US: Regulatory Affairs Specialist

Date: 16-Jul-2015
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Regulatory Affairs Specialist

Key Responsibilities: *Act as a core member on manufacturing and product development teams, providing Regulatory Affairs input and guidance throughout the product development cycle, and coordinating team inputs for submissions. *Evaluate changes to controlled documents for impact on submissions and filing requirements, including providing a technical review of and approval for proposed changes and supporting documentation. *Work closely with scientific, manufacturing and quality personnel to support the preparation of domestic and international regulatory submissions. This includes writing, reviewing and editing technical reports and regulatory documents. * Provide input on and review of protocols and reports for: design verification and validation for material, process and facilities changes, assay/method validation, shelf life, non-clinical studies, material qualification and safety testing. * Ensure regulatory compliance with QSR and cGMP requirements, as appropriate through customer feedback, internal/external audits, and training systems. *Manages and tracks submission of annual reports, certifications and licenses.

*Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.

Job Requirements : BS degree in life sciences or related scientific discipline. Advanced degree(s) and RAC a plus. 2+ years' relevant experience in related life sciences profession and a thorough understanding of biologics / tissue engineered product development and cGMP requirements. Previous experience in a regulatory affairs operations role preferred. Experience with combination (drug/device or biologic/device), biologic product or drug products is preferred. Working knowledge of FDA and International Biologics/Drug regulations; experience with CBER and/or IND, BLA, NDA regulatory submissions. In addition, working knowledge of Medical Device regulations or prior experience with device regulatory filings and product development is ideal. Strong organizational, interpersonal and written/verbal communication skills.

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