Remote Otter LogoRemoteOtter

Senior Director, Global Regulatory Affairs Labeling - Remote

Posted 22 weeks ago
All others
Full Time
Worldwide
$245,000 - $285,000 USD/year

Overview

The Sr. Director, Global Regulatory Affairs Labeling collaborates closely with BridgeBio regulatory teams and is a subject matter expert to support the development and implementation of regulatory labeling strategies and oversight of the global labeling activities.

In Short

  • Provide regulatory expertise and guidance for global labeling strategy.
  • Collaborate with regulatory teams and subject matter experts.
  • Lead the Label Working Group.
  • Maintain awareness of global regulatory environments.
  • Develop and document best-in-class labeling processes.
  • Oversee maintenance and development of CCDS and local labeling deliverables.
  • Review and approve change requests for labeling.
  • Prepare labeling strategic plans.
  • Review final artwork for production.
  • Travel up to 10%.

Requirements

  • Bachelor’s Degree in Pharmacy, Biology, Chemistry or related field.
  • 10+ years of pharmaceutical or regulatory experience.
  • Strong knowledge of US and EU product labeling requirements.
  • Excellent project management skills.
  • Strong communication and relationship-building abilities.
  • Ability to interpret laws and regulations.

Benefits

  • Patient Days to learn from individuals living with conditions.
  • A culture inspired by values of patient-first and transparency.
  • Access to learning and development resources.
  • Market-competitive compensation and benefits package.
  • Flexible PTO.
  • Rapid career advancement for strong performers.
BridgeBio logo

BridgeBio

BridgeBio is a biopharmaceutical company dedicated to discovering, creating, testing, and delivering transformative medicines for patients suffering from genetic diseases and cancers with clear genetic drivers. Founded in 2015, BridgeBio bridges the gap between groundbreaking advancements in genetic science and the delivery of meaningful therapies. The company has developed a diverse portfolio of over 30 drug development programs across various therapeutic areas, including genetic dermatology, precision oncology, and rare diseases, with a commitment to scientific excellence and rapid execution. With offices in the U.S. and international locations, BridgeBio fosters a culture that prioritizes patient needs, encourages independent thinking, and values transparency.

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