Assistant Director Regulatory Affairs North America Operations - Bayer Corporation

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Assistant Director Regulatory Affairs North America Operations  

The Assistant Director Regulatory Affairs North America Operations reports directly to the Head of Regulatory Affairs North America. The scope of the Operations position is to ensure organizational effectiveness of Regulatory Affairs North America.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Assistant Director Regulatory Affairs North America Operations, are to:

• Represent and support the Head of North America Regulatory Affairs to manage 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. Specifically, support information flow and management, businesses processes and organizational planning;
• Oversee and manage 90-day US regulatory outcome operational processes;
• Lead operational initiatives and meetings including, but not limited to, 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.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Advanced Degree is 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. is preferred in a relevant health science area;
• Experience in regulatory affairs and/or operations role preferred.

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