On-Board Scientific is hiring a Global Regulatory CMC Manager in New Brunswick (or Lawrenceville), NJ!
For immediate consideration please send your resume to
Subject Line : Position Title and State you are located
About Us :
On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees.
We offer benefits as well as 401k.
Position Details :
Position Type : Full-Time / 6 month
Job Location : New Brunswick, NJ – 50% onsite (Hybrid)
Benefits : 401K, Dental Insurance, Life Insurance, Medical Insurance, Vision Insurance
Compensation : $87.07
Prerequisities :
BS / BA degree in Scientific Discipline (Master’s or higher preferred) with
3-5+ years in the pharmaceutical industry, preferably with 2+ years CMC regulatory experience
Responsibilities will include, but are not limited to, the following :
Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
These submissions include health authority briefing packages, IND / CTA, BLA / NDA and MAA regulatory filings.
Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision.
Responsible for the global regulatory evaluation of CMC change controls with supervision.
Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision.
Represent Regulatory CMC on cross-functional development / commercial teams and Regulatory Affairs teams.
Participate in global regulatory interactions with health authorities, with supervision.
Facilitate document review meetings and discussions.
Develop and maintain knowledge of regulatory environment, regulations and procedures.
Skills / Knowledge Required :
Experience with CMC regulatory documents (IND / CTAs, BLA / NDAs, MAAs, responses, variations and briefing documents)
Knowledge of FDA, EMA and / or ICH guidelines and CMC regulations
Experience in drug development processes and post-approval requirements
Experience in developing CMC regulatory strategy
Experience in project management
Have a solution-oriented approach to problem solving
Ability to plan / prioritize work of group members and guide / develop others.
Ability to work on complex projects and within cross-functional teams with supervision
Excellent communication skills, both written and oral
Apply Today!
On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry.
Today, On-Board is a thriving privately held family of companies with services including : Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.
The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
On-Board’s Mission is to provide Flexible Service by applying the talents of our people, work processes and technology to meet our clients’ expectations in a Safe, Responsible and Dependable manner.
On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.
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INDOJ
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