REGULATORY OPERATIONS MANAGER
May 2, 2017
Edge Therapeutics, Inc. (Edge) is an entrepreneurial, fast-paced, dynamic
and collaborative, publicly-traded biotech company, with a lead product currently in Phase 3 clinical trials. http://www.pdsbiotech.com/
Situated in a lovely office park in Berkeley Heights, NJ, Edge’s offices are accessible, appealing, ample, and invite both private and group work. Small in number, big in vision, mission and values, Edge’s collegial, diverse, talented, and passionate team is striving to get potentially life-saving products to patients.
We are seeking a collaborative Regulatory Operations Manager, who will report directly to Edge’s SVP, Regulatory Affairs, and will be responsible for overseeing the operational aspects of all Edge submissions to U.S. and international Regulatory Agencies, in support of pre-and post-marketing submission compliance. This oversight includes managing the planning, tracking, coordinating, compiling, submitting, and archiving of submissions, and ensuring that the submissions are of the highest quality, delivered on-time, within the established budget, to meet U.S. and international regulatory requirements and company goals. Successful performance in this role will contribute meaningfully to Edge’s overall success.
We are eager to hear from you if you meet or exceed the following partial list of educational, experiential and skill requirements:
- Bachelor’s degree in a life science or relevant discipline
- Five (5) years (minimum) of in-depth regulatory operations experience in
pharmaceutical and/or biotech product development
- 7+ years of pharmaceutical or biotech industry experience
- Recent experience (within 2 years) successfully managing the creation and submission of regulatory documents that have been accepted on technical grounds at first pass
- Superior analytical and integrative thinking skills;; able to orchestrate plans to resolve issues and mitigate risk
- Live within commuting distance of Berkeley Heights, NJ
- You have proven ability to:
- Ensure continuous, compliant, and timely submissions capabilities
- Create and manage submission plans, from initiation through to approval and dispatch, for all Regulatory submissions (IND, NDA, MAA, Agency Responses, others), in conjunction with Regulatory Affairs, cross-functional colleagues, and global vendors
- Effectively communicate with internal and external key stakeholders
- Manage the publication and submission of regulatory documents in eCTD format
- Serve as the primary contact for the maintenance of IT tools used to support submissions
- Communicate with FDA on technical submission matters
Please write Regulatory Operations Manager in the Subject line and send a cover letter and resume to: firstname.lastname@example.org. We will respond promptly to individuals whose qualifications most closely match the position requirements.
RECRUITERS & STAFFING AGENCIES: Recruiting is handled internally. No solicitations by recruiters to any Edge employee will be accepted.