CMC Regulatory Scientist
Nesco Resource ·nescoresource.com
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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, high level of professionalism, 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.
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.
Performs other tasks as requested by management
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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, high level of professionalism, 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.
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.
Performs other tasks as requested by management
Nesco Resource offers a comprehensive benefits package for our associates, which includes a MEC (Minimum Essential Coverage) plan that encompasses Medical, Vision, Dental, 401K, and EAP (Employee Assistance Program) services.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Frequently asked questions
Who is hiring for the CMC Regulatory Scientist role?
Nesco Resource is hiring for the CMC Regulatory Scientist position, a Shazamme client. Apply directly on the employer's career site.
Where is the CMC Regulatory Scientist job located?
The CMC Regulatory Scientist role with Nesco Resource is based in Rahway, NJ, US.
What does the CMC Regulatory Scientist role pay?
Nesco Resource lists the CMC Regulatory Scientist role at USD 70–73 per hour.
Is the CMC Regulatory Scientist role full-time or contract?
This is a full time position at Nesco Resource.
What experience level is the CMC Regulatory Scientist role?
The CMC Regulatory Scientist position is aimed at mid-level candidates.
How do I apply for the CMC Regulatory Scientist role at Nesco Resource?
Apply directly on Nesco Resource's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.