Regulatory Affairs Operations Director

4 weeks ago


Whippany, New Jersey, United States Bayer Corporation Full time
Job Summary

Bayer is seeking a highly skilled Regulatory Affairs Operations Director to join our North America team. As a key member of our Regulatory Affairs team, you will be responsible for ensuring organizational effectiveness and operational excellence in Regulatory Affairs North America.


Key Responsibilities
  • Represent and support the Head of North America Regulatory Affairs in managing issues, process flows, meetings, and communications.
  • Play a significant role in short and long-term planning for RA North America, including initiatives geared towards operational excellence.
  • Oversee and manage 90-day US regulatory outcome operational processes.
  • Lead operational initiatives and meetings, including advisory board meetings, internal and external meeting planning/execution, and advisory committee preparations.
  • Responsible for creating and managing a strong network throughout Regulatory Affairs and with other key stakeholders, facilitating collaboration and culture.
  • Partner with the Head of Regulatory Affairs North America and finance to ensure FTE, regulatory budgets, and FDA submission fees are appropriately forecast, communicated, and spent.
  • Liaise with content experts to create presentations, meeting materials, reports, and spreadsheets to support regulatory activities.
  • Optimize regulatory processes through AI and automation.
  • Further develop, implement, and monitor consulting database, including identifying new US Regulatory consultants in partnership with stakeholders, ensuring fulfillment of consulting work, and feedback loop.
  • Manage issue resolution for Regulatory contracts.

Requirements
  • Advanced Degree required.
  • Strong understanding of business goals.
  • Strategic thinker with strong decision-making skills.
  • Strong Project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure.
  • Strong ability to communicate in both oral and written English, with persuasive and assertive negotiating skills.
  • Must possess advanced interpersonal and communication skills.
  • Must be able to provide creative solutions to complex problems.
  • Strong proficiency and experience with digital solutions.

Preferred Qualifications
  • Ph.D. or Pharm.D. preferred in a relevant health science area.
  • Experience in regulatory affairs and/or operations role preferred.


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