Description
Exciting Senior Regulatory Affairs Manager of Operations - New JerseyRare opportunity for a Senior Regulatory Affairs Manager of Operations at a fast growing pharmaceutical company in New Jersey with ample prospects for career advancement.
Job Description:
- Provide Regulatory Affairs Operation support including publishing and submission support
- Ensure submissions are timely and within budget
- Responsible for managing, designing and implementing processes to maximize electronic efficiency for submissions
- Prepares, tracks and archives paper and electronic submissions for annual reports, safety reports and INDs
- Act as liaison between multiple department including writing, clinical, publishing and safety
- Coordinate and publish annual reports, INDs, non clinical reports, and briefing packages
- Represent Regulatory Affairs Department on various submissions teams including INDs, NDAs, and Clinical Study Reports
- Familiar with FDA and EMA electronic submission requirements
- Able to lead multiple departments including writing, clinical, publishing, and safety
- Regulatory Affairs operations experience in formatting, publishing, submitting and archiving eCTD
Qualifications:
- BS degree with 7-8 years pharma industry experience
- Prior project NDA/MAA and management experience preferred
- Flexible to build relationships with colleagues across departments
- Experience in regulatory operations including formatting, publishing, submitting and archiving (eCTD) sequences
- Document Management Systems and publishing tools experience (Documentum, InSight Publisher, eCTDexpress)
- Ongoing understanding of FDA and EMA electronic submission requirements
- Comfortable developing processes across multiple departments
Salary $K
This is a perfect opportunity for a Regulatory Affairs Operations candidate that wants to grow within a global company! Don't miss out on this exciting career advancement opportunity!
Apply today!
Contact Deneen by phone at
To find out more about Real please visit www.realstaffing.com