Regulatory Compliance Specialist

Katalyst Healthcares and Life Sciences

United States

Responsibilities:

The Regulatory Compliance Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines projects.
The focus of this position will be to support a Veeva Vault Rim project requiring previous regulatory and Veeva Vault experience.
The RSO specialist will be the main project contact with support from the local RSO team.
Responsibilities will include testing and project support.
The Regulatory Compliance Specialist will ensure Regulatory compliance by providing support to batch release by checking submission/approvals, ensuring permanent regulatory/license compliance and reviewing and approving site documents (e.g. Standard Operating Procedures, Site Master File, Product License Commitments).
The Regulatory Compliance Specialist will manage the review, assessment, and coordination of submission requirements for changes proposed by the M&S organization.
Participates in meetings and follow-up activities required to ensure proper assessment of change controls.
The Regulatory Compliance Specialist manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing.
uthorizations and other documentation that support site registrations, specific country documentation, and Annual reports.
The Regulatory Compliance Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
The Regulatory Compliance Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required and serve as the Regulatory interface between M&S, MSAT and GRA.

Requirements:

Bachelor's Degree/Undergraduate Degree. Experience in pharmaceutical/biopharmaceutical industry or related regulatory, industry/manufacturing environment.
Well-developed communication skills, both verbal and written. Years of Experience: 2 - 6 Years.
Previous Veeva Vault Rim experience.
Project experience performing User Acceptance Testing for computerized systems.
Strong authoring skills of GMP and CMC documentation and Health Authority responses.
bility to manage multiple priorities efficiently.
bility to resolve strategic technical and regulatory issues.
Should demonstrate initiative, analytical thinking and works independently.
bility to work well with cross functional teams, and good communication skills with internal and external stakeholders.
Experience working with a Health Authority is helpful but not essential.
Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance and trends are helpful.

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Vacancy posted 3 days ago

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