Senior Regulatory Compliance Specialist
Cynet systems Inc, Swiftwater, PA, United States
Job Overview
Pay Range: $50.97/hr - $54.97/hr
The Regulatory Compliance Specialist II is responsible for supporting regulatory compliance activities within manufacturing and supply operations, with a focus on vaccines projects.
This role involves working closely with cross-functional teams to ensure compliance with regulatory requirements, supporting system implementations, and managing regulatory documentation and submissions.
The candidate will play a key role in ensuring adherence to global regulatory standards and supporting project execution.
Requirement/Must Have
Experience with regulatory systems and processes, including Veeva Vault RIM.
Experience in regulatory compliance within pharmaceutical or biopharmaceutical environments.
Strong authoring skills for regulatory and GMP documentation.
Experience performing user acceptance testing for computerized systems.
Ability to manage multiple priorities and work independently.
Strong analytical and problem-solving skills.
Excellent communication skills with internal and external stakeholders.
Experience
2–6 years of experience in regulatory, pharmaceutical, or manufacturing environments.
Responsibilities
Support regulatory compliance activities for manufacturing and supply teams.
Act as a key contact for regulatory system projects and provide project support.
Perform testing and validation activities for system implementations.
Ensure compliance with regulatory requirements for batch release and submissions.
Review and approve site documentation including standard operating procedures and regulatory files.
Manage submission requirements and coordinate regulatory changes.
Participate in meetings and follow up on change control activities.
Author regulatory documents to support marketing authorizations and site registrations.
Prepare responses to regulatory authority inquiries with support from subject matter experts.
Serve as a regulatory interface between cross-functional teams.
Should Have
Knowledge of global regulatory guidelines and industry standards.
Experience interacting with regulatory authorities.
Strong initiative and ability to work independently.
Ability to collaborate effectively with cross-functional teams.
Skills
Regulatory compliance and documentation.
Veeva Vault RIM and system validation.
GMP and CMC documentation.
Change control and submission management.
Communication and stakeholder coordination.
Qualification And Education
Bachelor’s degree in a relevant field.
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The Regulatory Compliance Specialist II is responsible for supporting regulatory compliance activities within manufacturing and supply operations, with a focus on vaccines projects.
This role involves working closely with cross-functional teams to ensure compliance with regulatory requirements, supporting system implementations, and managing regulatory documentation and submissions.
The candidate will play a key role in ensuring adherence to global regulatory standards and supporting project execution.
Requirement/Must Have
Experience with regulatory systems and processes, including Veeva Vault RIM.
Experience in regulatory compliance within pharmaceutical or biopharmaceutical environments.
Strong authoring skills for regulatory and GMP documentation.
Experience performing user acceptance testing for computerized systems.
Ability to manage multiple priorities and work independently.
Strong analytical and problem-solving skills.
Excellent communication skills with internal and external stakeholders.
Experience
2–6 years of experience in regulatory, pharmaceutical, or manufacturing environments.
Responsibilities
Support regulatory compliance activities for manufacturing and supply teams.
Act as a key contact for regulatory system projects and provide project support.
Perform testing and validation activities for system implementations.
Ensure compliance with regulatory requirements for batch release and submissions.
Review and approve site documentation including standard operating procedures and regulatory files.
Manage submission requirements and coordinate regulatory changes.
Participate in meetings and follow up on change control activities.
Author regulatory documents to support marketing authorizations and site registrations.
Prepare responses to regulatory authority inquiries with support from subject matter experts.
Serve as a regulatory interface between cross-functional teams.
Should Have
Knowledge of global regulatory guidelines and industry standards.
Experience interacting with regulatory authorities.
Strong initiative and ability to work independently.
Ability to collaborate effectively with cross-functional teams.
Skills
Regulatory compliance and documentation.
Veeva Vault RIM and system validation.
GMP and CMC documentation.
Change control and submission management.
Communication and stakeholder coordination.
Qualification And Education
Bachelor’s degree in a relevant field.
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