Regulatory Compliance Specialist II

Job Description

Job Summary:

• 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 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.

Duties and 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.

Educations and 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.
• Experience working on Project teams.

Knowledge, Skills and Abilities:

• Requires knowledge and understanding of CMC topics, as well as North American, European and International regulations/guidelines.
• Ability to manage multiple priorities efficiently.
• Demonstrated knowledge of microbiology, immunology, virology or bacteriology.
• Excellent skills in communication, writing and teamwork.