Senior Regulatory Affairs Specialist

2 days ago

Taiwan beBeeRegulatory Full time

We're seeking an expert in Regulatory Affairs to help shape the future of our industry.

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Our ideal candidate is a seasoned professional with a strong background in regulatory affairs, who can provide strategic direction and oversight for complex projects. They will be responsible for developing comprehensive CMC strategies to support product development, registration, and lifecycle management.

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Key Responsibilities:

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  • Provide strategic input on critical cross-project topics, ensuring alignment with overall business objectives">
  • Develop and oversee CMC strategies for complex regulatory submissions, including IND applications, IMPDs, BLAs, MAAs, post-approval variations/supplements, and responses to health authority questions">
  • Author and review high-level regulatory submissions, ensuring all submissions conform to relevant health authority guidelines and regulations">
  • Lead submission preparation meetings and coordinate cross-functional input">
  • Represent the company in high-level meetings with regulatory agencies and build positive relationships with key regulatory stakeholders">
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About You:

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Our ideal candidate has a deep understanding of evolving CMC regulations, guidelines, and industry best practices. They are a visionary leader with strong leadership skills, able to influence cross-functional teams and senior management. The ideal candidate is proactive, self-motivated, and committed to regulatory excellence.

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Desired Qualities:

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  • 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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What We Offer:

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We offer a competitive compensation package and a dynamic work environment that encourages growth and innovation. Our team is passionate about making a difference in the lives of patients and communities around the world.

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Become a Part of Our Team:

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If you're a motivated and experienced professional looking to make a meaningful impact, we encourage you to apply for this exciting opportunity.

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