Regulatory Affairs Manager jobs in Trenton, NJ

Job Description

Regulatory Affairs Manager

Duration: 2 years; possibility of conversion to FTE (not guaranteed)

Hourly Pay Rate: $60.00-$63.00/hour

Expected Weekly Hours/Schedule: 40 hours Mon thru Fri

Location: Princeton, NJ or San Diego, CA

*The manager would like the hire to start by April 15th, 2024.

strongly preferred; hybrid in office 3 days minimum per company policy. (Note: Candidates local in San Diego, CA are acceptable... but the Princeton, NJ is the preferred location.

Position Summary:

The Temporary Manager, Regulatory Affairs provides tactical and strategic support for development programs and post-marketing activities. This position will work, at the operational level with study teams and other RA functions to prepare IND/CTA and NDA submissions. In addition, this position will support various process initiatives to align the company with emerging regulatory requirements, and perform regulatory intelligence tasks as needed.

Primary Responsibilities:

· Coordinates and prepares document packages for regulatory submissions in alignment and compliance with local and regional registration requirements as well as with company policies

· Interacts effectively with functional departments in order to facilitate documentation requirements for submissions, ensuring departmental timelines are achieved. Communicates and coordinates regulatory activities with other departments, as needed

· Monitors and collects assigned deliverables required for regulatory submissions

· Compiles all materials in an orderly fashion to facilitate timely submission to the FDA

· Reviews submission materials for errors or other content issues prior to submission.

· Maintains regulatory files (including submissions and correspondence) for Investigational New Drugs (INDs), Clinical Trial Authorizations (CTAs) and other regulatory applications

· Completes regulatory forms at the direction of Regulatory management

· Assists in the preparation of Annual Reports, Development Safety Update Reports (DSURs), Investigator's Brochures and other documents required to maintain ongoing INDs, CTAs and other applications in good regulatory standing

· Reviews change controls for regulatory approval

· Reviews SOPs pertaining to Regulatory Affairs

· Participates in cross-functional project teams to facilitate activities associated with regulatory affairs

· Keeps project lead informed on status and timelines of pending submissions and any associated correspondence from Regulatory authorities

· Keeps abreast of regulatory procedures and changes

· Supports process initiatives related to new/emerging regulatory requirements, working with Regulatory Affairs colleagues and other functions to develop standard ways of working and process documents as needed

· Other duties as assigned

Education/Experience/Skills:

· Bachelor's degree in biology, chemistry or related science field

· Equivalent combination of relevant education and applicable job experience may be considered.

· Minimum of 5 years' experience in the pharmaceutical or related industry

· Regulatory and drug development experience is required Must possess:

· Ability to understand and explain detailed regulatory affairs and compliance programs and/or issues

· Ability to comply with changing regulatory procedures

· Ability to adapt to changing priorities and prioritize work effectively

· Strong Project Management capabilities required

· Excellent Microsoft Office skills

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marita
To apply please email your resume to bzhong@rothstaffing.com