Manager Regulatory Affairs

Biotech Company: Manager Regulatory Affairs

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Location:  Central New Jersey
Reports To:  Executive Director, Regulatory Affairs   
Compensation:  $80K - $90K base + bonus and benefits

Are you ready to join a growing, global biopharmaceutical that is making a difference?  We are seeking a high energy, dynamic leader who can hit the ground running and is ready for this exciting opportunity.  For immediate and confidential consideration, please send a Word version of your resume and note where you heard of this opportunity.

Summary

Reporting to the Executive Director, the Manager will have overall responsibility for preparing submissions to regulatory authorities.

Duties and Responsibilities

• IND maintenance (information amendments, SAE reports, annual reports, meeting notes, etc.)
• Assisting with coordinating and compiling documentation in support of BLA, NDA, and MAA filings.
• Production, archiving, and indexing of regulatory documents, in both electronic and hard copy formats.
• Interacting with internal departments to ensure regulatory activities occur as appropriate to support the submissions.
• Interacting with regulatory agencies and contract research organizations as needed.
• Organizing and maintaining the regulatory communications files.
• Creation and maintenance of regulatory project logs/databases, tracking the submission status of reports and other regulatory activities.
• Preparing documents for electronic submission.
• Responsible for communications and oversight of CROs preparing electronic submission documents.

Requirements:

• Bachelor’s degree (scientific or clinical background desirable.)
• 5+ current years experience in Regulatory Affairs in the pharmaceutical or biotechnology industry required.
• Must have experience with both paper and electronic submissions (eCTD), including submission writing and review experience. 
• Strong interpersonal and written/verbal communication skills.
• Excellent organizational, planning, and follow-up skills.  Must have ability to meet tight deadlines and be efficient, detail-oriented, flexible, and a self-starter.
• Excellent computer skills; MS Word and Adobe Acrobat are required. Experience with preparing submission-ready PDFs and use of Microsoft Excel highly desired.
• Travel commensurate with the job.