RSO Specialist (Regulatory Compliance Specialist)

Greetings from IT Engagements…!

IT Engagements is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. We have an immediate opening for the below position with one of our premium clients.

RSO Specialist (Regulatory Compliance Specialist II)

Swiftwater, Pennsylvania.

Description:

• 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

Regards,

Shashank Jaitly

Shashank@itengagements.com

Job Type: Contract

Pay: $35.00 - $45.00 per hour

Schedule:

• 8 hour shift

Work Location: In person

Salary : $35 - $45