ProClinical is currently seeking a Sr. Regulatory Affairs Associate for a multinational Pharmaceutical company with a focus on diabetes care medication and devices. This Senior RA Associate will be a contract position, based in Plainsboro, New Jersey.
- 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 more senior personnel in managing projects.
- 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.
- Coordinate document submission.
- In accordance with supervisor's requirements & 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.
- Manage assigned project responsibilities, compose routine draft correspondence relevant to projects as assigned, such as letters of response, transmittal and memoranda where applicable. Use of templated correspondence as appropriate, ensuring that all new information is correct.
- Prepare drafts of routine correspondence.
- Prepare ROCs for routine FDA contacts.
- Review documents.
- Review information from local & NNAS contributing departments and provides comments to assure that documents are accurate and complete and comply with FDA regulations.
Skills and Requirements:
- A Bachelor's Degree required; Life Science preferred.
- A Minimum of 3 years’ experience required (Pharmaceutical industry, laboratory, or clinical
- research position).
- Commitment to regulatory affairs profession.
- Effective personal time management.
- Excellent written skills.
- High commitment to quality of all assigned projects.
- Intermediate proficiency in Microsoft Office Suite required.
- Strong detail orientation.
- Strong interest in continuous improvement and professional development
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Christopher Frank on +1 267 405 6996 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.