Job Description
Job Title Synonyms
Job Description
Job Title Synonyms
Job Description
Regulatory Affairs Specialist (Hybrid)
3 days on-site in Bridgewater/2 days REMOTE
12 months
Kelly® Science & Clinical is seeking a Regulatory Affairs Specialist for our client in Bridgewater, New Jersey. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
Responsibilities:
Responsible for the review, proofreading, and QC of the components of assigned FDA submissions to assure accuracy of submission documents for IND/NDA/ANDA products. Individual must be proficient in WORD, EXCEL, Adobe Acrobat Pro, eCTD format requirements, and Controlled Document Management System (preferably Documentum). Additional responsibilities include Regulatory writing with a clear understanding and working knowledge of subject matter expert contributions (nonclinical, clinical and medical affairs) for application components of identified filing(s).
- Provide direct hands on /highly operational, administrative regulatory writing (cover letters, FDA forms, and other Module 1 documents, etc.), and support to prepare and review content of submissions to INDs, NDAs and ANDAs including annual reports, labeling and other non-CMC supplements and product correspondences.
- Support authoring of other subject matter expert contributed Modular sections as identified
- Work with Regulatory Management to make certain all product documentation is developed in accordance with regulatory requirements; serves as designee as needed
- Support the preparation of documentation and materials required for interactions with Regulatory Authorities as assigned
- Provide final documents to regulatory operations for e-publishing and submission in eCTD format
- Directly communicate with and support the Regulatory Product Leads and/or Director with assigned tasks.
- Advises the Regulatory Product Leads and/or Director of any delays in submissions or potential regulatory problems for investigational and marketed products.
Qualifications:
- Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Labeling, and post-market requirements
- Knowledge of domestic and international regulations laws, regulations, and guidance
- Knowledge of clinical development, including responsibilities for successful management of development milestones and market authorization
- Ability to assess project risks and where appropriate, escalate accordingly
- 3 - 5 years relevant pharmaceutical industry and regulatory experience (or 1+ years Pharmaceutical Brand Experience with a Master’s in Regulatory Affairs)
- Bachelor’s degree in science or health related field
What happens next
Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all of our recruiters will have access to your profile, expanding your opportunities even more.
Helping you discover what’s next in your career is what we’re all about,
#P1