Planet Pharma ยท 1 day ago
Regulatory Affairs Specialist
Irvine, CA
Full-time
Onsite
Senior Level
5+ years expPlanet Pharma is a company dedicated to regulatory affairs, and they are seeking a Regulatory Affairs Specialist to manage labeling deliverables and ensure compliance with various regulations. The role involves collaboration with cross-functional teams and maintaining regulatory documentation for product labeling.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Accountable for the regulatory labeling deliverables for various project types (i.e. submission, new product development, sustaining, launches, manufacturing transfer, etc.)
Manage and support assessment and template creation for new and changing requirements
Prepare technical product documentation including plans, reports, and engineering change orders, etc
Maintain artwork content for all labeling types including Instructions for Use documents, product labels, Patient labeling, electronic labeling, label stocks, and carton in compliance with applicable regulations, standards, company policies, processes as well as internal labeling requirements
Estimates labeling projects level of effort, resource requirements and works with stakeholders to understand the scope of effort and tasks necessary to complete the project
Collaborate with multi-functional team (R&D engineering, marketing, manufacturing, operations, regulatory, legal, quality, clinical, medical safety) to facilitate completion of labeling artwork projects
Tracks labeling project schedules, identify risks/issues, determine resolution and communicates project status or escalations by participating in departmental and project team meetings
Keeps abreast of regulatory procedures and changes
May direct interaction with regulatory agencies on defined matters
Manage labeling, UDI and barcode grading processes and systems as related to product labeling
Other duties as assigned or required
Qualification
Required
EU Labeling Requirements
Global labeling requirements, 21 CFR 801, EU MDR Regulation, ISO15223, ISO20417
Project Management and Change Management skills
MS in Science, engineering or regulatory
5-9 years of experience
Onsite - minimum 4 days
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase