Actalent Regulatory Affairs Specialist in Bridgewater, New Jersey
This opportunity is with a LEADING global pharmaceutical company dedicated to eye health research. They are looking to add a Regulatory Specialist to their team. This company has great culture and is rapidly growing! They are looking to interview as soon as this week!
Responsible for the review and evaluation of all FDA submissions to assure accuracy and completeness of submission documents for IND/NDA/ANDA products.
Determines submission requirements and requests needed data, information, and documentation from pertinent departments, facilities, and affiliates, and from contractors/vendors as needed. Liaises with partner companies as appropriate.
Reviews and provides comment for reports and amendments to INDs/NDAs, assuring submission within specified regulatory timeframes. Reviews and provides comment for accuracy and completeness all materials to be included in submissions, including materials prepared by others and supplied to Regulatory.
Responsible for preparing Regulatory Module 1 documents, including labeling markups and annotations for submission.
Interacts with all department, facilities, and affiliates with regard to investigational and marketed products for required information and documentation.
Contributor for regulatory guidance regarding investigational and marketed products (U.S. and Canada).
Advises Regulatory Management of any delays in submissions or potential regulatory problems for investigational and marketed products (U.S. and Canada).
Performs other projects, project-based tasks and/or special projects as assigned by Regulatory Management.
Additional Skills & Qualifications:
2-4 years of prior regulatory affairs experience
Basic module 1 authoring experience
MS office proficiency
You will need experience with word for forms/cover letters
Use excel for project tracking
Use Teams for project management
Project tracking and data entry
Project management system they use is Smartsheets
Insert data for submissions, view the dashboard to search countries and products, change dates and countries, assigning task, gathering information for projects.
Excellent communication and verbal skills
Authoring experience for letters and forms
1572 forms, 356H forms, cover letters
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.