Associate – Clinical Trial Label Regulatory Compliance

Role Summary

Associate – Clinical Trial Label Regulatory Compliance

Responsibilities

• Develop and maintain regulatory strategy for CT material labels and CT material regulations (including phrase library).
• Propose updates to process and procedures as regulations change to ensure compliance.
• Provide high quality and timely regulatory advice on CT material labels and CT material regulations to allow business partners to make well-informed decisions.
• Contribute to impact assessments on evaluation of regulation changes driving solutions that meet needs of the affiliate and the business.
• Coordinate with CT Label Regulatory Compliance management to manage issues, propose mitigation/response plans to resolve issues and effectively implement action plans for regulatory challenges/issues.
• Participate in interpretation and implementation of regulations impacting CT material across Clinical Supply and Delivery, Clinical, and Regulatory organizations through proactive and effective communication.
• Contribute and participate in periodic regulatory reviews of country regulations.
• Create and participate in change controls when standard processes must be modified or changed.
• Proactively identify ways to improve day-to-day activities and practices. Support efforts to improve productivity, efficiency, product quality and reduction of risk.
• Stay abreast of cGMPs, GDP‚Äôs, GCPs, and other regulatory requirements related to CT material labels and CT material regulations.

Qualifications

• Bachelor's degree in scientific or health science discipline (e.g. pharmacy, nursing, chemistry or related scientific discipline)
• 3 years industry-related experience in regulatory affairs, CT Labeling and/or drug development
• Knowledge of regulatory procedures and practices across regions (FDA, PMDA, etc) and awareness of evolving regulatory reforms and initiatives
• Knowledge of drug development process
• Demonstrated ability to assess regulations in multiple countries, experience in CT Material regulations preferred
• Strong proficiency with computer applications including Outlook and Microsoft Office.
• Strong interpersonal skills, including capability to engage in professional relationship building and networking.
• Strong written and verbal communication skills.
• Ability to manage multiple tasks, excellent attention to detail, strong organization, and self-management skills.
• Ability to work in an independent, flexible environment.
• Working knowledge of GCP regulations, MQS, and GMP/GDP requirements.
• Demonstrated critical thinking and problem-solving skills.
• Knowledge of Clinical Trial and Protocol Design
• Knowledge of procedural and regulatory requirements
• Must speak fluent English

Skills

• Project management
• CT Material Commercial Product sourcing
• TrackWise Experience

Education

• Bachelor's degree in scientific or health science discipline (e.g. pharmacy, nursing, chemistry or related scientific discipline)

Additional Requirements

• Work outside of core hours may be required to support the portfolio across the globe
• May require travel domestically and international (less than 10%)