Regulatory Affairs Associate
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Regulatory Affairs Associate coordinating global regulatory submissions for Parexel. Managing submissions and ensuring compliance with regulatory requirements while collaborating with cross-functional teams.
Responsibilities:
- Play a crucial part in coordinating various Global regulatory submissions ie. INDs, IMPDs, BLA/NDS/MAA post-approval commitments
- Assist in the preparation and coordination of global regulatory submissions, ensuring all submissions are complete, accurate, and compliant with regulatory requirements
- Manage submission timelines and coordinate with cross-functional teams to gather necessary documentation
- Support the team in conducting regulatory assessments of manufacturing changes, analyze the potential impact, and assist in preparing documentation to support manufacturing change assessments
- Facilitate effective communication between cross functional teams and regulatory authorities
- Participate and facilitate project team meetings to provide regulatory input and updates
- Maintain accurate and up-to-date regulatory documentation
Requirements:
- Strong labeling and artwork experience
- Solid project management skills
- Familiarity with seasonal vaccine activities
- US knowledge required
Benefits:
- Health insurance
- Professional development opportunities
Similar Jobs
FAA Regulatory Compliance Manager
FAA Regulatory Compliance Manager managing drone regulatory processes for public safety. Ensuring compliance and effective collaboration with teams on FAA authorizations and waivers.
Junior Compliance Analyst
Analista de Compliance Júnior at VERT supporting compliance regulations and client analysis in financial markets. Involves policy updating and regulatory report preparation, ensuring adherence to internal standards.
Regulatory Affairs Professional, Database
Regulatory Database Professional managing regulatory compliance for healthcare diagnostics. Ensuring audit readiness and supporting effective database use within the life sciences.
IT Clinical Solution Analyst IV – Registry/Regulatory
IT Solution Analyst IV supporting healthcare applications in design and implementation for Registry and Regulatory reporting. Collaborating with teams to ensure accurate project timelines and communications.
Senior Consultant, Workforce Compliance & Employment Law
Senior Consultant at Artemis Connection specializing in workforce compliance and employment law. Engaging in a project with a focus on legal guidance for a technology organization.
Customs Compliance Analyst
US Customs Compliance Analyst overseeing daily U.S. import operations for FormFactor, Inc., ensuring compliance with customs regulations and optimizing import flows.
Healthcare Risk Management and Compliance Specialist
Risk Management and Compliance Specialist responsible for risk assessment and mitigation in healthcare settings. Expertise in Texas regulations and collaborative operations for Axiom.
Subject Matter Expert – Regulatory Compliance
Subject Matter Expert providing environmental regulatory compliance and consulting at Olsson. Leading projects and mentoring multidisciplinary teams in environmental planning and analysis.
Compliance Manager
Compliance Manager at Solar Landscape ensuring adherence to regulatory requirements across federal, state, and local jurisdictions in renewable energy.
M&A Extended Workforce Playbook Development, Risk & Compliance
Consultant developing a scalable M&A playbook for the Extended Workforce Solutions Risk & Compliance team at a technology company. Ensuring compliance and operational scalability through structured frameworks.
Compliance & Regulatory Strategy
Building compliance processes and controls for a fintech company while complying with Latvian and EU regulations. Transforming regulatory requirements into operational specifications and automated workflows.
Compliance Analyst
Compliance Analyst leading customer engagement to ensure project management excellence for Hewlett Packard Enterprise. Responsible for team management and bid proposal execution in a remote work environment.
Regulatory Affairs Consultant – Medical Device, Combination Product Expert
Regulatory Affairs Consultant leading medical device regulatory strategies for Parexel. Providing guidance on regulatory pathways and serving as the key regulatory representative for global teams.
Senior Manager, Logistics – Trade Compliance
Senior Manager overseeing logistics operations and ensuring trade compliance at tonies. Managing domestic and international logistics activities while focusing on operational excellence and regulatory adherence.
Senior Director, Global Regulatory Lead
Global Regulatory Lead overseeing regulatory strategies for Immunome's oncology portfolio. Collaborating with teams to ensure compliance and drive product success through innovative regulatory challenges.
Chief Compliance Officer – Fractional
Chief Compliance Officer leading compliance efforts for virtual care services at Wheel. Responsible for ensuring adherence to healthcare regulations and managing compliance strategies.
Pricing Compliance Analyst III
Pricing Compliance Analyst III supporting federal contracting pricing compliance and audit activities for Amentum. Ensuring adherence to Federal regulations and accuracy in proposal pricing documentation.
Pricing Compliance Analyst IV
Pricing Compliance Analyst IV at Amentum ensuring pricing strategies meet legal standards and internal policies while leading audit activities. Requires extensive knowledge of Federal acquisition and pricing data regulations.
Environmental Compliance Manager
Environmental Compliance Manager responsible for leading compliance strategy for NY construction project. Collaborate with teams to integrate environmental requirements and manage permits for successful execution.
Senior Specialist, Quality Compliance, External Affairs
Quality Compliance External Affairs Specialist managing global pharmacopoeial programs. Coordinating cross-functional teams to ensure compliance and document management within the biotech firm.