Regulatory Affairs Consultant- R&D
Elanco Tiergesundheit AG, Indianapolis, IN, United States
**At Elanco (NYSE: ELAN) – it all starts with animals!****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!**# **Supervisor Title**:
Director, US Regulatory Affairs**Job Level**:
P3**Position Type**:
Full Time**Job Function**:
Regulatory Affairs**Location**:
USA/Canada**Your Role:** Regulatory Affairs Consultant- R&D 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.**Your 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: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work EnvironmentDon’t meet every single
have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!**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 matchingElanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected statusElanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‐related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our**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.**Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose(TM) CSR framework – all to advance the health of animals, people and the planet. Learn more at . #J-18808-Ljbffr
Director, US Regulatory Affairs**Job Level**:
P3**Position Type**:
Full Time**Job Function**:
Regulatory Affairs**Location**:
USA/Canada**Your Role:** Regulatory Affairs Consultant- R&D 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.**Your 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: Global Elanco Headquarters - Indianapolis, IN - Hybrid Work EnvironmentDon’t meet every single
have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!**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 matchingElanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected statusElanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‐related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our**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.**Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose(TM) CSR framework – all to advance the health of animals, people and the planet. Learn more at . #J-18808-Ljbffr