Regulatory Affairs Associate
Planet Pharma, Santa Clara, CA, United States
We are seeking a detail-oriented and proactive Regulatory Affairs Operations Specialist (Contingent Worker) to support our Regulatory Affairs team. This role plays a key part in ensuring compliance with international regulatory requirements, maintaining high-quality documentation standards, and supporting cross-functional initiatives across global markets.
Summary Of Responsibilities
Drive implementation of new international regulatory requirements, ensuring procedures are current and compliant with applicable guidance and requirements.
Lead quality system process improvement initiatives
Prepare KPI dashboards and maintain a pulse on internal Regulatory Affairs (RA) metrics.
Coordinate pan-franchise requests for multiple products, including scheduling and facilitating meetings with international stakeholders
Submit and track addendum labeling requests.
Liaise with cross-functional partners, distribution centers, and international affiliates to align on regulatory requirements, documentation, addendum labeling, and regulatory letters.
Pan Franchise Specialist – Santa Clara
Key Tasks And Initiatives
Prepare and submit certificates to Foreign Governments (CFG) requests via the FDA database.
Maintain tracker and review Declarations of conformity (DoC).
Ensure adherence to Good Documentation Practices (GDP).
Manage translation requests using the Acolad portal.
Review EU MDR DoC translations for accuracy and consistency.
Review Regulatory Letters and maintain tracker for Letter of Authorization (LoA), Power of Attorney (PoA), tenders, controlled substances and evidence of conformance letters.
Maintain up-to-date trackers, SharePoint sites, and documentation repositories.
Support change management activities, including change orders (CO) for DoC templates and quality system procedures.
Establish emerging issues within the quality system.
Participate in RA projects and continuous improvement initiatives.
Troubleshoot regulatory issues in collaboration with international regulatory affiliates.
This role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
Skills
Independent
Troubleshooting
Critical thinker
Ability to drive a problem through resolution and implement mitigations
Ability to handle multiple streams simultaneously
Pay ranges between 30-40/hr based on experience.
#J-18808-Ljbffr
Summary Of Responsibilities
Drive implementation of new international regulatory requirements, ensuring procedures are current and compliant with applicable guidance and requirements.
Lead quality system process improvement initiatives
Prepare KPI dashboards and maintain a pulse on internal Regulatory Affairs (RA) metrics.
Coordinate pan-franchise requests for multiple products, including scheduling and facilitating meetings with international stakeholders
Submit and track addendum labeling requests.
Liaise with cross-functional partners, distribution centers, and international affiliates to align on regulatory requirements, documentation, addendum labeling, and regulatory letters.
Pan Franchise Specialist – Santa Clara
Key Tasks And Initiatives
Prepare and submit certificates to Foreign Governments (CFG) requests via the FDA database.
Maintain tracker and review Declarations of conformity (DoC).
Ensure adherence to Good Documentation Practices (GDP).
Manage translation requests using the Acolad portal.
Review EU MDR DoC translations for accuracy and consistency.
Review Regulatory Letters and maintain tracker for Letter of Authorization (LoA), Power of Attorney (PoA), tenders, controlled substances and evidence of conformance letters.
Maintain up-to-date trackers, SharePoint sites, and documentation repositories.
Support change management activities, including change orders (CO) for DoC templates and quality system procedures.
Establish emerging issues within the quality system.
Participate in RA projects and continuous improvement initiatives.
Troubleshoot regulatory issues in collaboration with international regulatory affiliates.
This role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
Skills
Independent
Troubleshooting
Critical thinker
Ability to drive a problem through resolution and implement mitigations
Ability to handle multiple streams simultaneously
Pay ranges between 30-40/hr based on experience.
#J-18808-Ljbffr