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26 days old

Regulatory Affairs Associate

Kelly Services
Mahwah, NJ 07430
**Regulatory Affairs Associate**


**Mahwah, NJ**


**Full Time**


**M-F, 8:00AM-5:00PM**


**Hybrid: 3 days onsite and 2 days remote**


Kelly Science & Clinical is looking for a **Regulatory Affairs Associate** to support the US Regulatory Affairs office of a Global pharmaceutical R&D company located in **Mahwah, NJ** . This role be primarily providing labeling support, but will also be trained and be capable of submitting controlled correspondences for R&D through CDER NextGen Portal, coordination of U.S. Rx and controlled substance licensing activities, obtain certificates of pharmaceutical products (CPPs) from FDA for foreign applications, submitting FARs & Recalls to the Agency, organizing Annual Reports for submission to FDA, preparing the Label Change Notification Form (LCNF), organizing administrative information for PADERS such as FORM 356H and the current label, shipping samples to the FDA for CDRH evaluation of devices.


**RESPONSIBILITIES**


+ Secondary/Back-up Reviewer for U.S. Labeling Backup label reviewer must be detail oriented and can perform label comparison checks using a comparison tool, such as TVT and/or Global Vision, while identifying deviations/discrepancies for generics, OTCs and NDA products.

+ Must be able to annotate artwork files to request revisions from Graphic Artists for discrepancies; perform comparison checks for other artwork files (bottle labels, cartons, blisters) against previously approved labels and RLD labels

+ For original ANDAs

+ Perform comparison check against RLD

+ For package insert, check Source documents (CMC module 3, trade dress) against package insert for dosage forms and strength, description, how supplied/storage

+ For all other package components, check against the RLD labels being included in ANDA submission

+ Perform comparison check against all labeling components in ANDA submission

+ RLD Updates:

+ For package insert, perform comparison check

+ Create comparison report, review for deviations/discrepancies and save the report to the respective product folders.

+ Confirm validity of deviations/discrepancies

+ Annotate artwork file as required with comments to GLM and save to the product folder

+ For all other artwork, perform visual comparison check against last approved artwork file and current revised file

+ For OTC products (non-ANDA and non-monograph)

+ Retrieve current artwork files from DailyMed for brand

+ Perform comparison checks of artwork files using comparison tool for insert files

+ Create comparison report, review for deviations/discrepancies and save the report to the respective product folders.

+ Confirm validity of deviations/discrepancies found in TVT report

+ Annotate artwork file as required with comments to GLM

+ Perform visual comparison check for other files (cartons, bottle labels, blisters)

+ Send annotated file to GLM

+ Send a copy of the outer carton artwork file to legal for review of disclaimers/trademark statements.

+ Coordination of U.S. Rx and controlled substance licensing activities for all U.S. States, as applicable

+ Submission of controlled correspondences for R&D through CDER NextGen Portal

+ Procure certificates of pharmaceutical products (CPPs) from FDA for foreign applications,

+ Submission of FARs & Recalls to the Agency,

+ Organizing Annual Reports for submission to FDA, preparing the Label Change

+ Notification Form (LCNF),

+ Organizing administrative information for PADERS such as FORM 356H,

+ Shipping samples to the FDA for CDRH evaluation of devices.

+ Other activities as assigned.


**QUALIFICATIONS**


+ B.S. in Chemistry or Biology, or Engineering degree in Biotechnology or Chemical Engineering

+ 1-2 years experience in a pharmaceutical company.

+ Preferably, the candidate should have labeling experience but its not mandatory. The selected candidate must have a willingness to work & learn about the pharmaceutical / generic drug industry and the U.S. regulations including the labeling regulations.

+ Excellent communication skills including verbal, reading, and writing.

+ Use various labeling software tools such as TVT and Global Vision.

+ Proficient using MS word, MS excel, reviewing Drugs@FDA databases, USP database, FDA Orange Book, and Dailymed Labeling.

+ The successful candidate must be proactive in reading and understanding assigned materials including FDA guidance documents pertinent to labeling.

+ The candidate must be a highly motivated, willing to be trained and learn to execute assigned tasks with attention to the details.

+ This role will require training on Standard Operating Procedures (SOPs), in-person training, and training by viewing FDA SBIA learning on-line video seminars.

+ Consider obtaining regulatory affairs (RAC) certification after one year of employment.

+ Read FDA guidance(s), USP general monographs, ICH guidelines as assigned accordingly.

+ Use critical thinking skills and ask questions when in doubt.Leadership / Managerial Attributes

+ This position does not manage people but must have excellent leadership skills and the successful candidate must be self-motivated.


P#3

Send resumes to Jacqueline.Sayoc@KellyScientific.com


**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.


**Why Kelly** **** **Science & Clinical?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
Posted: 2022-09-02 Expires: 2022-10-03

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Regulatory Affairs Associate

Kelly Services
Mahwah, NJ 07430

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