Senior Regulatory Affairs Specialist

Há 4 dias

Brasil beBeeLabeling Tempo inteiro US$91.234 - US$123.456
Regulatory Affairs Expert

We are seeking a highly skilled Regulatory Affairs Associate to join our team. This is an exciting opportunity for someone who is passionate about regulatory compliance and has excellent communication skills.

Key Responsibilities:

  • Demonstrate a thorough understanding of the structure and authorizing requirements for US Prescribing Information (USPI) and Canada Product Monographs.
  • Utilize advanced Microsoft Word editing skills, specifically for structured labeling documents.
  • Interact directly with clients, addressing their needs and queries related to labeling processes and requirements.
  • Ensure all labeling documents comply with regulatory standards and guidelines.
  • Collaborate with cross-functional teams to coordinate labeling activities and timelines.
  • Stay updated on regulatory changes and industry best practices in labeling.

Qualifications:

  • Bachelor's degree in Life Sciences, Pharmacy, or a related field (advanced degree preferred).
  • Minimum of 3-5 years of experience in regulatory affairs or labeling within the pharmaceutical industry.
  • In-depth knowledge of global regulatory labeling requirements, with a focus on EU, US, and Canadian markets.
  • Proficiency in advanced Microsoft Word features, particularly those related to structured labeling.
  • Excellent written and verbal communication skills in English.
  • Strong attention to detail and ability to manage multiple projects simultaneously.
  • Proven experience in client-facing roles within the pharmaceutical or healthcare industry.

**Required Skills:**

  • Expertise in regulatory labeling processes and timelines.
  • Proficiency in authoring and editing USPI and Canada Product Monographs.
  • Advanced Microsoft Word skills, particularly in structured labeling techniques.
  • Strong interpersonal and communication skills for effective client interactions.
  • Ability to work independently and as part of a team in a fast-paced environment.

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