Regulatory Operations/Affairs Manager
Regulatory Operations/Affairs Manager
United Consulting Hub
New Brunswick, NJ
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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
to new manufacturing facilities and process changes.
annual reports.
Qualifications, Knowledge And Skills Required
approval.
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
- Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at
to new manufacturing facilities and process changes.
- Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical
annual reports.
- Support product release by managing appropriate systems to ensure product market compliance to enable
- Review of local and global change controls, deviations, CAPA’s, technology transfer plans, and regulatory submission
- Maintains strong communication and working relationships with all departments, contract manufacturing
- Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s,
Qualifications, Knowledge And Skills Required
- The successful candidate will have a minimum of 3 years Quality/Compliance/Technical experience in a
- Regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous.
- Bachelor's Degree in a related field
- Ability to work independently and within team matrix environments.
- Ability to manage teams associated with individual aspects of responsibilities, direct people management and
- Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working
- In depth knowledge of Quality Management Systems with an emphasis on change control principles and the
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.
-
Seniority level
Mid-Senior level -
Employment type
Contract -
Job function
Legal -
Industries
Pharmaceutical Manufacturing
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