Manager, CMC Regulatory Affairs

Job ID 17-00142

Industry Pharma

Job Type Permanent

Location Cranbury, NJ


Manager, CMC Regulatory Affairs manages all regulatory CMC aspects of company throughout their lifecycle with minimum supervision. This includes early development, development/scale up, and commercial products. He/She is responsible for the integration of the regulatory CMC strategy of all submissions and managing interactions with external regulatory consultant services on CMC issues.

Prepare, author, review, coordinate, manage or maintain simple and complex regulatory submissions, including original INDs, IND amendments, IMPDs, annual reports and agency meeting briefing documents in accordance with applicable regulations
Translate regulatory requirements into practical, workable submission plans
Develop and maintain submission timelines for CMC related issues
Coordinate the authoring, review and comment resolution for related submissions
Provide thoughtful & accurate comments during document review with focus on US, international, and ICH regulatory guidelines
Interface with external regulatory groups, such as contract manufacturers, development partners, consultants and technical writers
Act as liaison between Regulatory Affairs and other functional areas
Represent Regulatory Affairs in cross-functional team meetings
Initiate and/or contribute to process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments
Review and communicate current and emerging regulatory requirements
Author and review standard operating procedures (SOPs)
Develop and maintain current regulatory knowledge


The successful candidate must possess a Bachelor's degree in pharmacy, or process manufacturing related healthcare functional area.
Advanced Scientific or Process Engineering degree is desirable
Regulatory Affairs Certification is preferred
Background in biologics manufacturing process, process validation, and project management are required.
The candidate must have 3 to 5 years of regulatory experience in the pharmaceutical or biotechnology industry as it pertains to CMC regulatory affairs or biologics manufacturing process
Experience working in small molecule is desirable
The candidate must have a solid understanding of FDA regulations, international regulations and the ICH guidelines, as well as a comprehension of the drug development process
Experience with regulatory submissions in Common Technical Document format.
The candidate must be able to handle multiple projects simultaneously, while exercising good judgment in prioritizing tasks.
The candidate must demonstrate the ability to work independently as well as in matrix team settings.
The candidate must have strong oral, written, and interpersonal communication skills.The candidate must also have a high level of attention to detail with proficiency with Microsoft Office applications, Adobe and document management templates.
Minimum travel requirement