Regulatory Compliance Specialist III (Engineering)

Job Description

Immediate need for a talented Regulatory Compliance Specialist III (Engineering). This is a 05+months contract opportunity with long-term potential and is located in Swiftwater, PA (Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID : 25-90321

Pay Range : $50 - $62 / hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key 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 Regulatory affiliates with the contribution of site experts.
• may participate in transversal activities by serving as a 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.
• Regulatory Compliance :
• Supports batch release by following submission and approval to ensure the product regulatory compliance on his / her sites(s)
• Response to agency lot release questions
• Ensures that the dossier is in line with manufacturing and control procedures on site(s) and with dossiers approved by Health Authorities
• Prepares and provides Regulatory documentation required for site registration and renewal activities
• Documentation Management :
• Writes and approves regulatory documents / dossiers to be dispatched to regulatory affairs functions for submissions
• Coordinates writing performed by another entity (internal or external)
• Optimizes the content of dossiers to facilitate the management of future changes
• Prepares response to questions from Health Authorities with the contribution of site experts
• Supports Marketing Authorizations worldwide (territory extensions, renewals, site registrations and transfers, etc.) by writing the corresponding documents / dossiers and collecting GMP-related documents from the site(s)
• Consolidates regulatory activities in a planning tool
• Transversal Activities :
• Contributes to Regulatory intelligence on the specific field of competencies and communicates the appropriate information to the site
• Contributes to the implementation of the appropriate company tools to manage activities
• Contributes to site inspections and audits
• Attends and contributes Regulatory site expertise to designated Projects, Committees, and Team meetings
• May contribute to Critical Process Analysis and Testing Strategies
• Organizational Reporting and Communication :
• Responsible for reporting on the progress and specific issues pertaining to project / product responsibilities.

Key Requirements and Technology Experience :

Our client is a leading Pharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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