Job Description

Our Regulatory Affairs Team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

We are seeking a Growth and Improvement minded Associate Regulatory Affairs Director that can help drive our Strategic Operating Priorities.

Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs

Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)

Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape

Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world

Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us

Summary, Focus and Purpose

The Associate Regulatory Affairs Director is a lead role responsible for managing direct reports and ensuring regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations. 

Key Functions

Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion

Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and/or post license of US Biologicals | Serve as RA lead for designated R&D species and licensed products

Serve as an Alternate Liaison with the USDA for pre and/or post-regulatory responsibilities to include submissions and communications with the USDA, internal company departments and international permittees | Communicate as appropriate to direct in line manager communications or concerns

Review and prepare regulatory submissions in support of new licenses or licensed biologicals with the USDA | Prepare Standard International Dossiers and review registration documents for export markets where applicable

Supervise direct report personnel with priorities, development and performance management

Education

Bachelor's degree in Scientific, or related areas of study with ten years regulatory experience.....OR, a Master's degree in Scientific or related areas of study with five years regulatory experience, in the vaccine or pharmaceutical industry

Experience | Skills | Knowledge

Required

Strong working knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines

Efficient and effective time and project management skills

Principled people, communication and leadership skills for involvement with cross departmental teams

Desired

Antibody Therapeutics experience desired

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.