Regulatory Affairs Associate
Proclinical is currently recruiting for a Regulatory Affairs Associate with a pharmaceutical company located in Plainsboro, NJ.
- Advise stakeholders of submission completion.
- As requested, find information/potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward.
- Assist in preparation of regulatory documents.
- Assist Manager/Director in review of labelling for marketed products and new products as assigned.
- Assist with technical preparation for FDA meetings, including review of draft questions and supporting documents.
- Compile applications and prepare for sign-off (INDs/NDAs/BLAs/510ks, IND amendments & Annual Progress Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA communications, among others as assigned), assure submission to government agencies in support of investigational and marketed products is completed in accordance with supervisor's requirements and guidance.
- Maintain up-to-date knowledge of data requirements and formats, applicable current SOPs, regulations, and guidelines, and proactively provides guidance to ROI staff as needed during assembly of regulatory submissions.
Skills and Requirements:
- Bachelor's degree required; relevant experience and/or certification in specialized Regulatory function may be substituted for degree when appropriate.
- A minimum of 1 year experience required (Pharmaceutical industry, laboratory, or clinical research position).
- Veeva Vault RIM experience preferred
- Commitment to regulatory affairs profession
- High commitment to quality of all assigned projects
- Intermediate proficiency in Microsoft Office Suite required
If you are having difficulty in applying or if you have any questions, please contact Samantha Reader at 267-983-0134.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.