Regulatory Affairs Specialist

JOB FUNCTION: Scientific
JOB TYPE: Temp to Hire
LOCATION: Hanover, NJ
COMPENSATION: Not Specified
REMOTE / ONSITE: Onsite
POSTED: Nov 18, 2022

Our client is an American-based pharmaceutical company seeking to hire a Regulatory Affairs Specialist to join their team.

Salary/Hourly Rate:

Dependent on relevant, recent industry experience

Position Overview:

Our client is looking to add a Regulatory Affairs Specialist to their team to provide support for current and developing products.

Responsibilities of the Regulatory Affairs Specialist:

  • Assess impact of new regulations and guidance
  • Provide timely assessment and verification of raw materials and developmental materials in order to assure compliance
  • Collect and collate data required for registration submissions
  • Prepare submission packages for the appropriate regulatory agency
  • Act as the liaison for the company and8upport including QC checks and compliance/ regulatory database entry and reports
  • Create submission documentation such as folders, metadata forms, RA request forms
  • Ensure documentation is eCTD compliant, Document formatting (DA) checked, finalized and eCTD filenames assigned
  • Coordinate data/KPIs required for reports within RA CMC
  • Coordinate, prepare and track CMC submissions for delivery to RA Operations
  • Acquire and maintain GMP certificates and manufacturing authorizations required for RA CMC submission in the Document Management System

Qualifications of the Regulatory Affairs Specialist:

  • Must demonstrate excellent written and verbal communications skills
  • Deep understanding of claims review and approval and regulatory compliance
  • Outgoing/self-starting personality who is able to work independently
  • Able to work in a collaborative environment
  • Effective planning and organizational skills
  • Computer literacy and excellent data processing skills
  • Previous experience in pharmaceutical, cosmetic, or consumer goods industry
  • Prior authoring and publishing experience is highly desired

Education Requirements:

  • Bachelor’s or Master’s degree in a Science field

Benefits:

  • Medical
  • Dental
  • Vision
  • 401k
  • Life insurance
  • PTO
As a woman-owned firm, we value diversity. We are an equal opportunity employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Position ID: 116152