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Job Requirements of Regulatory Compliance Specialist II:
-
Employment Type:
Contractor
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Location:
Swiftwater, PA (Onsite)
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Regulatory Compliance Specialist II
Careers Integrated Resources Inc
Swiftwater, PA (Onsite)
Contractor
The RSO Specialist will work closely with the Manufacturing and Supply teams, and Regulatory CMC colleagues on Vaccines site-based projects to manage change controls, product license commitments and submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets. The RSO Specialist will have responsibility for one or more products or activities in the RSO Vaccines group.
The RSO 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 RSO 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 RSO Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports.
The RSO Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
The RSO 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.
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
Strong authoring skills of GMP and CMC documentation and Health Authority responses
Ability to manage multiple priorities efficiently
Ability to resolve strategic technical and regulatory issues
Should demonstrate initiative, analytical thinking and works independently
Ability 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
The RSO 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 RSO 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 RSO Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports.
The RSO Specialist prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
The RSO 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.
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
Strong authoring skills of GMP and CMC documentation and Health Authority responses
Ability to manage multiple priorities efficiently
Ability to resolve strategic technical and regulatory issues
Should demonstrate initiative, analytical thinking and works independently
Ability 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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