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Title : MKG- Regulatory Scientist Assistant II (Associate) -423
State : New Jersey   Date : Apr 13, 2021
Experience Level :  
Position Type : Regulatory Scientist Assistant II (Associate)      
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: Madison, NJ  

Job Title: Regulatory Scientist Assistant II (Associate)

Duration: 12+ months (extendable) contract on W2


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.
  • 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.

Many Thanks,   

Sree Kanth
Recruitment Manager

NewAgeSys, Inc.
Direct: 609-945-1736 Fax: 609-228-4079
600 Alexander Rd, Suite 3-3 
Princeton , NJ 08540 
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