Regulatory Compliance Specialist III (Engineering)

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:

• Key Skills: Regulatory Affairs
• Modules 1.2, 2.3, and 3
• Pharma industry/Biologics
• Vaccines/Health Authority/Health Authorities
• compliance
• Veeva Vault/Veeva
• SOP/Documentation
• Strong authoring skills in documentation and Health Authority responses
• Ability to resolve strategic, technical, and regulatory issues
• Should demonstrate initiative, analytical thinking, and work independently
• Ability to work well with cross-functional teams, and good communication skills with internal and external stakeholders
• Experience working with a Health Authority is helpful but not essential
• Knowledge of global regulations/guidelines, key Health Authority/Industry Guidance, and trends is helpful.
• 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

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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