Quality - Regulatory Operations Manager Job New Brunswick area,New Jersey USA,Quality Assurance

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:

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.

Candidate Attributes:

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.

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