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27 days old

Sr. CMC Specialist

Kelly Services
Madison, NJ 07940
**SUMMARY OF POSITION**


The Senior Specialist is responsible for developing 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.


**MAJOR ACTIVITIES AND 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 in order 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


**BACKGROUND REQUIREMENTS**



**Education:**


Bachelor of Science degree (minimum) in science, engineering, or other relevant field (advanced degree preferred).


**Experience**


+ At least 2 years of relevant experience (for example: pharmaceutical research, manufacturing, or quality)

+ Proficient in English

+ Experience reviewing scientific information, demonstrated oral and written communication skills

+ Demonstrated understanding of related fields (manufacturing, testing, and quality assurance), leadership skills (problem solver, ability to deal with multiple priorities, strong interpersonal skills, sound judgement and attentive to details).

+ Previous CMC experience is preferred.


**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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Sr. CMC Specialist

Kelly Services
Madison, NJ 07940

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