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Manager – Regulatory Affairs CRO
Manager – Regulatory Affairs CRO
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Location: Central New
Jersey (part-time
available)
Compensation: Competitive
Salary
Are you ready to join a growing, CRO that is making a difference? We are seeking high energy, dynamic colleagues who can hit the ground running and are 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
The Manager will have
overall responsibility for
preparing submissions to
regulatory authorities and
working with external and
internal partners.
Duties & Responsibilities:
- IND maintenance (information amendments, SAE reports, annual reports, meeting notes, etc.)
- Understand and communicate SOP’s and scope of work as measured against timelines.
- Assisting with coordinating and compiling documentation in support of relevant 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.
