About The Position

We have a great opportunity for an Associate Principal Scientist to join our global team. We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We use the power of leading-edge science to save and improve lives around the world. Join us in our mission to shape and facilitate the strategic plan and ongoing transformation of our CMC organization, part of Global Regulatory Affairs and Clinical Safety (GRACS). What you will do: Bring energy, knowledge, innovation, and leadership to carry out the following:

Requirements

  • Minimum of 5 years’ experience in regulatory affairs, 2+ years’ experience in project and change management
  • Strong collaboration and communication skills.
  • Ability to manage complex projects and initiatives with limited supervision.
  • Strong digital skills and familiarity with digital tools and platforms is required
  • Enterprise mindset with an ability to think strategically across the organization.
  • Experience in managing cross-functional teams and working with strategic partners.

Nice To Haves

  • Experience with CMC regional regulatory strategies is preferred though not essential

Responsibilities

  • Lead, support or project manage the design and implementation of cross-regional or functional business strategies, process improvement initiatives, and operating model projects in collaboration with our strategic partners.
  • Support communication on initiatives progress and implementation, keeping the organization informed and supporting associated change management activities.
  • Coordinate and contribute to the delivery of the Regional CMC strategic plan, operating model transformation initiatives, and key priorities.
  • Support the management of Regional CMC priorities, roadmap, scorecards, and dashboards.
  • Digital transformation, including supporting Digital capabilities build in the Regional CMC team.
  • Strengthen Regional CMC’s partnerships with other GRACS and broader enterprise stakeholders across regions, including other GRACS functions, our research & development division functions, and other divisions (HH: Sales, Marketing, our manufacturing division: Supply Chain, Quality).
  • As required, develop CMC regional regulatory strategies for new marketing applications and post-approval changes.
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