Senior Regulatory Associate


Job ID 17-00250

Industry Pharma

Job Type Permanent

Location East Windsor, NJ

Description

Want to work for a top Generic Pharma company with lots of growth potential? How about a company that you can be promoted quickly and be recognized for your work? We have a direct relationship with our Hiring Managers and can get you in for the interview! This client provides great benefits and bonus structure as well. Apply with us today!

ESSENTIAL DUTIES & RESPONSIBILITIES
50 Weekly Presubmission review of Client Pharma sterile product ANDA documents (chemistry and labeling for new submissions, amendments, supplements and annual reports) for completeness and
conformance to FDA and internal company requirements.
20 Monthly Coordinate with project partners and/or 3rd party manufacturers to assure required tasks are performed and documentation is obtained per project timeline and is suitable / acceptable for submission to FDA.
10 Ad Hoc Compilation and publishing of Client Pharma submissions (for partnered and/or 3rd party manufactured projects).
10 Ad Hoc Issuance / maintenance of Client NDC number list; review of proposed new product labeling for compliance to FDA requirements and corporate format; providing information and documents needed for new product launches to Sales / Marketing as needed.
10 Ad Hoc Backup for QA documentation review and release of incoming shipments.
 

OTHER RESPONSIBILITIES
Search FDA databases to determine existing competition for proposed new projects. Knowledge and ability to search FDA regulations and guidances / presentation materials to develop strategies for complex products. Perform other duties as assigned.



Qualifications

QUALIFICATIONS PREFERRED & REQUIRED
Bachelor's degree. Minimum 2 - 3 years of pharmaceutical Regulatory Affairs experience preferably in generics including at least 1 year experience in review of labeling / eCTD Module 1 documents. Familiarity with applicable regulations and guidances including current Office of Generic Drugs submission requirements, ICH, cGMP etc. Some Regulatory Operations experience (submission compilation and publishing) helpful but not required. Master's degree in RA/QA beneficial but not required.
 

LICENSES, CERTIFICATIONS, MEMBERSHIPS, ETC.
RA Certification (RAC) a plus but not required.
 

LEADERSHIP SKILLS & ABILITIES
Must be goal-oriented and strategically focused on achieving the shortest time frame from project inception to successful product launch. Must also be willing / able to reject clearly deficient documents or strategies and specify the corrective action needed / viable path forward.
 

MANAGEMENT SKILLS & ABILITIES
Excellent written / verbal communication skills a must. Able to prioritize tasks and work calmly and accurately under tight submission timelines. Ideally, possesses ability to resolve conflicts with creative paths forward that are acceptable to all stakeholders.