CMC Regulatory Scientist

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). 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.

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Job Title: CMC Regulatory Scientist (#MSD1JP00003858)
Location: 126 East Lincoln Avenue, Rahway, MA 07065 United States (Hybrid)
Duration: 06+ Months Contract

Pay Rate: $73.30/Hr on W2

Shift: Monday through Friday, 8:00 AM - 5:00 PM – 40 Hours/Week  
 
(Job Details)
 
Previous CMC experience. Regulatory Affairs / CMC submission experience. Experience with quality, analytical, R&D method validation, or validation package preparation. Familiarity with regulatory submissions, dossier updates, CTD, renewals, variations/supplements, and responses to regulatory authority questions. Experience with global regulatory systems such as Veeva Vault. Knowledge of EU/US regulatory expectations and guidelines such as FDA-CVM, EMA, and VICH.
 
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

 
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.

 
Notes:

• Rahway, NJ
• Hybrid (3 days onsite, 2 days WFH)
  Tuesday and Wed(core onsite days)

 
Why Work With Us?
We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.

Our Commitment to Inclusion & Equity
Net2Source is an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.

Awards & Recognition
• America's Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1

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