Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 9 Month(s)
Skills
Collaboration
Communication
Documentation
Immunology
Management
Manufacturing
Marketing
Job Details
We are looking for Senior Regulatory Compliance Specialist for our client in Swiftwater, PA
Job Title: Senior Regulatory Compliance Specialist
Job Type: Contract
Job Description:
Pay Range: $51.97hr - $54.97hr
Responsibilities:
- The Regulatory Specialist may have responsibility for one or more products or activities in the RSO Vaccines group.
- Manages the authoring of regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that supports site registrations, specific country documentation, and Annual reports.
- Prepares responses to Health Authority questions from Regulatory affiliates with input from site experts.
- May participate in transversal activities by serving as Regulatory interface between M&S, MSAT and GRA.
- Ensures Regulatory compliance by providing support to batch release, checking submission/approvals, ensuring permanent regulatory/license compliance and reviewing and approving site documents (e.g. Standard Operating Procedures).
- May represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required.
- Bachelor s degree in Biological Sciences with 2+ years Regulatory Affairs experience OR Master s degree in Regulatory Affairs/Quality Assurance or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing.
- Ability to manage multiple priorities efficiently.
- Experience working on Project teams.
- Demonstrated knowledge of microbiology, immunology, virology or bacteriology.
- Excellent skills in communication, writing and teamwork.
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