Administrative Skills, Biotech and Pharmaceutical, Change Control, Communication Skills, Contract Manufacturing, Corrective and Preventative Action (CAPA) Systems, Documentation, Establish Priorities, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Internal Audit, Interpersonal Skills, Maintain Compliance, Manufacturing, Manufacturing Requirements, Manufacturing/Industrial Processes, Multitasking, Operations Management, Organizational Skills, People Management, Product Support, Product/Service Launch, Project/Program Management, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Regulatory Submissions, Risk Management, Standard Operating Procedures (SOP), Supply Chain, Systems Administration/Management, Team Lead/Manager, Team Player, Time Management
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.