Kelly Services Senior Regulatory Affairs Specialist CMC in Madison, New Jersey
Senior Specialist, Regulatory Affairs CMC
Kelly Science and Clinical is currently recruiting for two qualified, full-time, fully-benefited, Senior Regulatory Specialists in Madison, NJ for one of our clients. The need to fill these positions are immediate and are long-term contract assignments. These positions are a part of the Animal Health Research and Development division in the Global Regulatory Affairs department of a highly reputable company.
Summary of the Position:
The Senior Specialist is responsible for developing Chemistry, Manufacturing, and Control (CMC) regulatory submission strategies and timelines for assigned pharmaceutical projects/products in accordance with global regulations and guidance. The Senior Specialist is also responsible for the preparation and review of information required for development of regulatory CMC dossiers for new and existing commercial products.
Work independently and effectively with other functions to manage and prepare regulatory CMC dossiers, renewals/annual reports, variations/supplements, and responses to authority questions as required in each country to gain new and maintain existing product registrations
Assess post approval changes, provide regulatory filing strategies and timelines, identify risks, and propose mitigation strategies
Ensures important submissions/tasks are completed on a timely basis
Actively participate on new product development teams as well as other types of teams and initiatives and deliver on all assigned regulatory milestones
Maintain regulatory information in accordance with processes and procedures to support regulatory compliance
Continuously build and share knowledge of CMC related regulations and guidelines (including but not limited to FDA-CVM, EMA, and VICH), authority expectations, as well as current industry standards
Identify and communicate potential regulatory issues to management, as needed
Perform other tasks as requested by management
Bachelor’s of Science degree in science, engineering, or other relevant field required; Advanced degree preferred
At least 2 years of relevant experience in pharmaceutical research, manufacturing, or quality required
Proficient in English
Excellent oral and written communication skills required
Demonstrated understanding of related fields, such as manufacturing, testing, and quality assurance
Leadership skills, including problem solving, able to deal with multiple priorities, sound judgement, and attention to detail
Previous CMC experience preferred; however, experience in R&D preparing reports that filter into the CMC section or experience in Quality will be considered in lieu of CMC experience
A COVID-19 Vaccination mandate requirement
Hours: This role is on-site in a hybrid model: 2 days on-site and 3 days remote; however, one of the on-site days must be Monday. During training, the candidate will be required to be on-site for training and then may move to a hybrid model thereafter.
This is a global role and a great chance to learn and grow with one of the top pharma companies in the world. You will manage your own projects and be challenged to deliver results. Take advantage of this wonderful employment opportunity today!
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 ® ?
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.
About Kelly ®
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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)