Regulatory Affairs Expert

1 week ago

Singapore beBeeRegulatory Full time $90,000 - $120,000

Job Title: Regulatory Affairs Expert - APAC

About the Role

We are seeking an experienced Regulatory Affairs expert to join our team in the Asia Pacific region. The successful candidate will be responsible for navigating the complex regulatory landscape, ensuring the success of diverse clinical trials.

Key Responsibilities
  • Lead submissions to regulatory authorities and coordinate with ethics committees across EMEA, Asia Pacific, and Latin America.
  • Develop and implement strategies to ensure compliance with evolving regulations.
  • Mentor junior staff and review key documentation for global regulatory standards.
  • Provide expert regulatory advice and contribute to regulatory project work.
  • Educate colleagues on regulatory requirements and best practices.
Requirements

To be successful in this role, you will need:

  • A minimum of 5 years' experience within the pharmaceutical/CRO industry, with demonstrated senior-level regulatory or clinical start-up experience across the APAC region.
  • Proficient in cross-cultural communication and proficient in both spoken and written English.
  • An understanding of ICH GCP and country-specific regulations.
  • Strong planning, strategizing, managing, monitoring, scheduling, and critiquing skills.
  • Excellent written and verbal communication skills to clearly and concisely present information.
About Us

We are a global CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe.

We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity.

We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful.

What We Offer

We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

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