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25 days old

Regulatory Affairs Project Manager

Kelly Services
Somerville, NJ 08876
**Regulatory Affairs Project Manager**


**Somerville, NJ**


**Full Time**


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


Kelly Science & Clinical is looking for a **Regulatory Affairs Project Manager** to support a company that provides proven regulatory strategy expertise, electronic submission capability, CM&C technical writing support, US/Regulatory Agent services, and effective preparation and coaching for Sponsor/FDA meetings in **Somerville, NJ** . The broad client list for this company includes large multinational pharmaceutical corporations as well as small, virtual, and biotechnology start-ups.


**Responsibilities**


(1) Coordinate with US and international clients to provide regulatory strategy, guidance, and submission support


+ Plan, write and prepare documents for submission to FDA and international Health Authorities supporting clients investigational and marketing applications.

+ Author and compile regulatory documents to support INDs, NDAs, BLAs, ANDAs and DMFs.


(2) Monitor, prioritize, and supervise multiple projects at different stages of development


+ Proactively communicate with clients throughout the project to establish strategy and timelines, agree on content and format of the submission, review/assess submission documents, including gap assessment.

+ Represent companies as their designated Regulatory/US Agent.


(3) Coordinate and manage all eDRLS submissions to ensure compliance


+ Manage, review, submit and maintain Facility GDUFA Self Identification, PDUFA updates, Labeler Code Requests, Establishment Registrations and Drug Listings.

+ Monitor DAILYMED and Establishment Registration database and confirm all submissions are listed correctly.

+ Communicate with FDA eDRLS and SPL teams as needed.


(4) Work with senior staff to help formulate and execute regulatory strategy as well as author submissions to support all activities related to FDA meetings.


(5) Ensure compliance with regulations and applicable guidelines.


**Qualifications**


Knowledge of regulatory sciences as demonstrated through a combination of work experience and academic background:


+ Prior professional experience in pharma, bio tech, or medical devices companies.

+ Prior experience with regulatory submissions and interactions with the FDA or other Health Authorities.

+ Prior experience with eDRLS submissions.

+ Knowledge and experience with eCTD.

+ Interpret and apply regulations as they apply to specific project issues: 21 CFR, FDA, ICH, or other regulatory agency guidance requirements.

+ Experience in a consulting environment is a plus.

+ BS/BA in Regulatory Sciences or Life Sciences. RAC and/or MS/Ph.D. are a plus.


Send resumes to Jacqueline.Sayoc@KellyScientific.com


\#1


**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.

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Posted: 2022-07-15 Expires: 2022-09-08

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Regulatory Affairs Project Manager

Kelly Services
Somerville, NJ 08876

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