Regulatory Affairs Specialist

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Job description

Regulatory Affairs Specialist

Kelly Services has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a with our client, a leader Regulatory Affairs Specialist in a leading pharmaceutical company, located in Bridgewater, NJ.

3 days on site in Bridgewater

2- days REMOTE

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.
• Performs other projects, project-based tasks and/or special projects as assigned by Regulatory Management.

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 Masters in Regulatory Affairs)
• Bachelor's degree in science or health related field

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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