Regulatory Affairs Expert for Pharmaceutical Innovation

Há 7 dias


Lisboa, Lisboa, Portugal Mygwork Tempo inteiro

We are seeking a highly skilled Regulatory Affairs Expert to join our team at Organon, a leading healthcare company dedicated to improving women's health. The ideal candidate will have a strong background in pharmaceutical innovation and regulatory compliance.

Job Description:

  • To develop and implement global regulatory strategies for assigned products in accordance with international regulations and guidelines.
  • To prepare and review information required for development of regulatory submissions, including life-cycle maintenance and post-approval changes.
  • To collaborate with cross-functional teams to ensure compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.

Required Skills and Qualifications:

  • Bachelor's degree in a science, engineering, or related scientific field with at least four years of relevant work experience, or Advanced degree with two years of experience.
  • Minimum of two years of relevant CMC experience, including biological/pharmaceutical research; manufacturing, testing or a related field.
  • Excellent communication and interpersonal skills, with the ability to generate innovative solutions to complex regulatory problems.
  • Familiarity with regulatory guidelines for product post-approval change management and data requirements.

Annualized Salary Range: $120,000 - $180,000

Benefits:

  • Comprehensive benefits package, including medical, dental, and vision coverage.
  • 401(k) plan with employer matching contributions.
  • Generous paid time off policy.

Others:

  • No relocation is required for this position.
  • No visa sponsorship is provided.
  • The ideal candidate must be proficient in English, with additional language skills a plus.


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