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Regulatory Affairs Consultant

Regulatory Affairs Consultant

ParexelRemote, Taiwan
4 天前
職務描述

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 :

  • 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

    • Health Authority Interactions :

  • 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

    • Regulatory Assessment and Change Management :

  • 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

    • Project Management and Leadership :

  • 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

    • Cross-functional Collaboration :

  • 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

    • Regulatory Intelligence and Innovation :

  • 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

    • Desired Qualities :

  • 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
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    Consultant • Remote, Taiwan