Regulatory Affairs Promotional Review Consultant

Responsibilities

• Maintain a broad overview of all post-approval activities related to assigned products and/or areas of responsibility.
• Provide regulatory guidance in the development and approval of promotional materials for the Elanco US Affiliate to support the food animal and pet health marketed pharmaceutical products and new launches.
• Support post-approval label changes, CMC updates, periodic reports and other post-approval submissions to FDA-CVM. This may include but is not limited to compilation, submission and archival.
• Lead project teams to comply with non-standard post-approval requests and authority mandates.
• Collaborate with other functional areas (Global CMC, Marketing, Legal, Technical, Labeling, Supply Chain, Quality, etc.) and external partners to promote regulatory awareness of and compliance with applicable regulations and internal policies and procedures.
• Represent Elanco in direct communications with FDA-CVM, in written form and by leading meetings as required by the project.
• Maintain positive business collaboration and influence with Elanco Reg Affiliates, Reg Innovation, FDA-CVM and industry groups.
• Perform other related duties and assignments as required by the business and directed by management.
• What You Need to Succeed (minimum qualifications):
• Master's degree or equivalent with at least 5 years relevant work experience within the sciences or related areas.
• Solid understanding of US FDA-CVM regulatory post-approval requirements
• Strong ability to interpret and leverage scientific data for promotional purposes while maintaining compliance with regulations.
• What will give you a competitive edge (preferred qualifications):
• Experience with promotional material/technical material review in the FDA/EPA space.
• Self-management skills in an environment with diverse needs and demanding, and often urgent, timelines
• Demonstrated ability to collaborate across organizations and develop compliant solutions that meet the needs of all parties.
• Strong oral and written communication skills and attention to detail
• Additional Information:
• Domestic and international travel, up to 5%
• Location: Indianapolis, IN
• Elanco Benefits and Perks:
• We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:
• Multiple relocation packages
• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)
• 8-week parental leave
• 9 Employee Resource Groups
• Annual bonus offering
• Flexible work arrangements
• Up to 6% 401K matching

Benefits

Additional Information

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: R egulatory Affairs Promotional Review Consultant Represent the Regulatory US Affiliate to ensure regulatory compliance and timely submissions for post-approval regulatory activities related to assigned pharmaceutical (FDA-CVM) products and/or areas of responsibility. Additionally, demonstrate leadership by providing innovative solutions, promoting a positive work environment, and effectively communicating to ensure delivery and maintenance of Elanco's food animal and pet health pharmaceutical portfolio.

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