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Title

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Scientific Affairs Manager

Description

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We are looking for a Scientific Affairs Manager to lead and coordinate scientific and regulatory strategies that support the development, approval, and marketing of our products. This role is critical in ensuring that our scientific communications are accurate, compliant, and aligned with both internal goals and external regulatory requirements. The Scientific Affairs Manager will serve as a key liaison between internal departments such as R&D, Regulatory Affairs, Marketing, and external stakeholders including regulatory agencies, healthcare professionals, and scientific communities. The ideal candidate will have a strong background in life sciences, excellent communication skills, and a deep understanding of regulatory environments. You will be responsible for developing scientific content, supporting clinical development strategies, and ensuring that all scientific claims are substantiated and compliant with applicable regulations. This position requires a strategic thinker who can translate complex scientific data into clear, actionable insights for both internal and external audiences. In this role, you will also contribute to the preparation of regulatory submissions, scientific publications, and educational materials. You will monitor scientific trends and regulatory changes to ensure our strategies remain current and effective. The Scientific Affairs Manager will also play a key role in training internal teams on scientific and regulatory topics, ensuring consistent and accurate messaging across all channels. This is a dynamic and collaborative role that offers the opportunity to make a significant impact on the success of our products and the advancement of science within our organization. If you are passionate about science, communication, and regulatory excellence, we encourage you to apply.

Responsibilities

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  • Develop and implement scientific communication strategies.
  • Serve as a liaison between R&D, Regulatory, and Marketing teams.
  • Ensure scientific accuracy and regulatory compliance of all materials.
  • Support clinical development and regulatory submission processes.
  • Create and review scientific content for publications and presentations.
  • Monitor scientific and regulatory trends relevant to company products.
  • Train internal teams on scientific and regulatory topics.
  • Collaborate with external experts and regulatory agencies.
  • Review and approve promotional and educational materials.
  • Provide scientific support for product launches and lifecycle management.

Requirements

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  • Advanced degree in life sciences (PhD, PharmD, or equivalent preferred).
  • 5+ years of experience in scientific affairs or related field.
  • Strong understanding of regulatory guidelines and scientific principles.
  • Excellent written and verbal communication skills.
  • Experience with regulatory submissions and scientific publications.
  • Ability to translate complex data into clear messaging.
  • Strong project management and organizational skills.
  • Proficiency in Microsoft Office and scientific databases.
  • Ability to work cross-functionally and manage multiple priorities.
  • Detail-oriented with a commitment to accuracy and compliance.

Potential interview questions

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  • What is your experience with regulatory submissions?
  • Can you describe a time you translated complex data for a non-scientific audience?
  • How do you stay current with scientific and regulatory trends?
  • What scientific writing experience do you have?
  • How do you ensure compliance in scientific communications?
  • Describe your experience working cross-functionally with other departments.
  • What therapeutic areas are you most familiar with?
  • Have you worked with external regulatory agencies before?
  • What tools or software do you use for scientific documentation?
  • How do you prioritize multiple projects with tight deadlines?