Currently I have an opening for a Regulatory Affairs Specialist located in Swiftwater, PA (Hybrid Schedule). Details for the position are as follows:Job Description:
- Will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and CMC colleagues on Vaccines site-based projects to achieve submissions and approvals in key markets and to maintain regulatory compliance for License registrations in existing markets.
- Supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities.
- 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.
- Prepares responses to Health Authority questions related to CMC from Regulatory affiliates with the contribution of site experts.
- Participates in transversal activities by serving as Regulatory interface between M&S, MSAT and GRA.
- 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).
- Supports batch release by following submission and approval to ensure the product regulatory compliance on his/her sites(s).
- Writes and approves CMC regulatory documents/dossiers to be dispatched to regulatory affairs functions for submissions.
- Bachelors degree in Biological Sciences with 2+ years Regulatory Affairs experience OR Masters degree in Regulatory Affairs/Quality Assurance or an appropriate combination of other relevant industry experience e.g., Quality and/or Manufacturing.
- Requires knowledge and understanding of CMC topics, as well as North American, European, and International regulations/guidelines.
Technical Information:
- Pay: $50-58 hourly, depending on experience level
- Onsite 2-3 days per week
- 6-month contract with potential for extension/conversion