Regulatory Operations/Affairs Manager

Job Description: Regulatory Operations/Affairs Manager

Onsite role

New Brunswick, NJ

Work Schedule: Mon - Fri, Business Hours

The External Manufacturing Quality Organization is seeking to recruit a Manager, Regulatory Affairs who will report directly to the Associate Director, Regulatory Affairs and will be responsible for all regulatory support activities within External Manufacturing.

Key Responsibilities Will Include, But Not Limited To

• Working as part of a team dealing with global market registrations and providing regulatory compliance/Affairs
  
  

guidance, and support to all External Manufacturing groups.

• Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at
  
  

all nodes of the supply chain for new product introductions, and post approval variations including but not limited

to new manufacturing facilities and process changes.

• Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical
  
  

Reports, CoA’s, Analytical raw data) to support regulatory requests for post approval variations, renewals, and

annual reports.

• Support product release by managing appropriate systems to ensure product market compliance to enable
  
  

seamless release of finished product to the market.

• Review of local and global change controls, deviations, CAPA’s, technology transfer plans, and regulatory submission
  
  

plans.

• Maintains strong communication and working relationships with all departments, contract manufacturing
  
  

organizations, and global personnel such as CMC.

• Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s,
  
  

quality risk management).

Qualifications, Knowledge And Skills Required

• The successful candidate will have a minimum of 3 years Quality/Compliance/Technical experience in a
  
  

biopharmaceutical Affairs role.

• Regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous.
• Bachelor's Degree in a related field
  
  

The Candidate Should Be Able To Demonstrate

• Ability to work independently and within team matrix environments.
• Ability to manage teams associated with individual aspects of responsibilities, direct people management and
  
  

project management aspects.

• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working
  
  

knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements.

• In depth knowledge of Quality Management Systems with an emphasis on change control principles and the
  
  

applicability of restriction/regulatory holds in the release process for changes that require health authority

approval.

• Ability to assess the right balance between the business implications, technical considerations and quality decisions.
• Excellent organizational and administration skills are required in addition to strong interpersonal skills.
• The successful candidate must be able to prioritize, organize and manage multiple tasks to tight deadlines.