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US-MA-Needham: Regulatory Affairs Scientist in Biotech

Date: 31-Jan-2012
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Regulatory Affairs Scientist in Biotech

# Involvement in short term and long term regulatory drug development and submission strategies for products in clinical and commercial development internationally and in the U.S. # Plan, manage and coordinate authors to generate regulatory documents; shepherd these documents through internal cross departmental review cycles for scientific adequacy; collect and manage resolution of comments from internal departmental reviewers to finalize documents; assemble and submit regulatory filings (e.g., IND) to national authorities within specified deadlines # Perform regulatory operations functions such as editing documents in MS Word, using electronic submissions software to generate eCTD submissions and electronically submitting them through the FDA Electronic Submissions Gateway # Maintain an organized paperless submission archive for U.S. and international submissions # Review manufacturing and change control documents, environmental monitoring reports and other various technical reports # Perform other job related duties * Scientific understanding of the FDA and ICH biotechnology-derived medicinal product drug regulations (and global regulatory requirements a plus) * Experience with IND, CTA, BLA submissions a plus * eCTD paperless submission experience a strong plus * Good communication and negotiation skills * Ability to work independently and as part of a team Education/Experience:

* BS/MS in life sciences with 24 years Regulatory Affairs experience or PhD in life sciences with 02 years Regulatory Affairs experience

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