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Regulatory Affairs Consultant
ParexelRemote, Taiwan5 天前
職務描述Develop and oversee CMC strategies for complex regulatory submissions, including : Investigational New Drug (IND) applicationsInvestigational Medicinal Product Dossiers (IMPDs)Biologics License Applications (BLAs)Marketing Authorization Applications (MAAs)Post-approval variations / supplementsResponses to health authority questions Author and review high-level regulatory submissions Ensure all submissions conform to relevant health authority guidelines and regulations Lead submission preparation meetings and coordinate cross-functional input Lead regulatory CMC discussions and interactions with Health Authorities Represent the company in high-level meetings with regulatory agencies Develop strategies for addressing complex regulatory questions and issues Build and maintain positive relationships with key regulatory stakeholders Oversee regulatory assessments of manufacturing changes Establish data requirements and strategies for regulatory submissions related to manufacturing changes Provide expert guidance on CMC-related regulatory implications of proposed changes Represent Regulatory CMC at high-level project team meetings and governance committees Lead critical submission preparation meetings and regulatory strategy discussions Address complex reviewer comments and manage sensitive regulatory correspondence Provide regular updates to senior management on project status, risks, and key milestones Mentor and develop team members in Regulatory CMC practices and strategic thinking Work closely with senior leaders across various departments, including R&D, Manufacturing, Quality Assurance, and Clinical Development Facilitate effective communication between internal teams, external partners, and regulatory authorities Provide expert CMC regulatory guidance to support critical business decisions and product lifecycle management Stay at the forefront of evolving CMC regulations, guidelines, and industry best practices Drive the development and implementation of innovative CMC regulatory strategies Participate in and potentially lead relevant industry groups and regulatory authority initiatives Visionary leader with the ability to anticipate and navigate complex regulatory challenges Strategic thinker with a talent for innovative problem-solving and risk management Strong leadership skills with the ability to influence cross-functional teams and senior management Proactive and self-motivated with a commitment to regulatory excellence Adaptable to changing priorities and evolving regulatory landscapes Excellent interpersonal skills with the ability to build strong relationships with internal and external stakeholders Detail-oriented with a focus on quality and accuracy, while maintaining a big-picture perspective Ability to thrive in a fast-paced environment and manage competing priorities
When our values align, there's no limit to what we can achieve.
Strategic Leadership :
- Provide strategic direction and oversight for CMC aspects of late-stage and marketed products
- Deliver strategic input on critical cross-project topics, ensuring alignment with overall business objectives
- Develop comprehensive CMC strategies to support product development, registration, and lifecycle management
Regulatory Strategy and Submissions :
Health Authority Interactions :
Regulatory Assessment and Change Management :
Project Management and Leadership :
Cross-functional Collaboration :
Regulatory Intelligence and Innovation :
Desired Qualities :
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Consultant • Remote, Taiwan
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