Regulatory Compliance Specialist III (Engineering) in Swiftwater

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Job Description

Regulatory Compliance Specialist III (Engineering

Swiftwater PA, 18370

6 Months (Possible Extension)

Description:

The Regulatory Specialist will work closely with the Regulatory Site Office, Manufacturing and Supply teams, and 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.

The position is based in Swiftwater, PA USA. This is a hybrid position.

The Regulatory specialist in Regulatory Site Office supports regulatory compliance for marketed products by means of compliant and timely handling of regulatory activities at Swiftwater. The incumbent manages regulatory activities linked to change controls for the site, including the update of files. The incumbent is accountable for product license maintenance and site registrations. The incumbent also ensures the role of regulatory expert for regulatory topics and projects at the Swiftwater and Pearl River sites.

Responsibilities:

The Regulatory Specialist may have responsibility for one or more products or activities in the RSO Vaccines group.

- manages authoring of 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 from Regulatory affiliates with the contribution of 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 by 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.

Experience:

• 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

• Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines

• 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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