Regulatory Affairs Consultant - Research and Development job at reputed company in Indianapolis, IN

Title: Regulatory Affairs Consultant- R&D Location: Guelph United States Job Description: At reputed company (NYSE: ELAN) - it reputed company 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 reputed company, we are driven by our vision of Food and Companionship Enriching Life and our purpose - reputed company to Go Beyond for Animals, Customers, Society and Our People. At reputed company, we pride ourselves on fostering a diverse and inclusive work environment. We reputed company 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 reputed company makes life reputed company - join reputed company 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 reputed company 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 reputed company's food animal and pet health pharmaceutical portfolio. Your Responsibilities: Maintain a broad overview of reputed company post-approval activities reputed company to assigned products and/or areas of responsibility. Provide regulatory guidance in the development and approval of promotional materials for the reputed company 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. reputed company project teams to reputed company 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 reputed company 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 reputed company Reg Affiliates, Reg Innovation, FDA-CVM and industry groups. reputed company other reputed company 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 reputed company the sciences or reputed company areas. Solid understanding of US FDA-CVM regulatory post-approval requirements Strong ability to interpret and reputed company 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 reputed company compliant solutions that meet the needs of reputed company parties. Strong oral and written communication skills and attention to detail Additional Information: Domestic and international travel, up to 5% Location: Global reputed company Headquarters - Indianapolis, IN - Hybrid Work Environment Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At reputed company 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! reputed company 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 reputed company 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 reputed company, protected veteran status, disability or any other legally protected status reputed company may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑reputed company criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not reputed company hiring decisions. reputed company decisions involve a human reviewer. Apply tot his job Apply To this Job