Senior Specialist, Regulatory Affairs CMC

Kelly Science and Clinical is currently recruiting for one 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.

Responsibilities:

• 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

Qualifications/Education/Skills:

• 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

Pay: TBD

Hours: This role is on-site in a hybrid model: 3 days on-site and 2 days remote; however, everyone must come to site Tuesday and Wednesday OR Monday and Thursday. 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!

Senior Specialist, Regulatory Affairs CMC

Kelly Science and Clinical is currently recruiting for one 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.

Responsibilities:

• 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

Qualifications/Education/Skills:

• 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

Pay: TBD

Hours: This role is on-site in a hybrid model: 3 days on-site and 2 days remote; however, everyone must come to site Tuesday and Wednesday OR Monday and Thursday. 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.

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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)