Regulatory Affairs Director jobs in Indiana

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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Regulatory Affairs Specialist - EPA
  • US01 Elanco US Inc.
  • Indianapolis, IN FULL_TIME
  • 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. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise. 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: Regulatory Affairs Specialist As a Regulatory Affairs Specialist at Elanco, you will be an integral part of the team responsible for overseeing regulatory compliance and post-approval management of EPA (Environmental Protection Agency) and NASC (National Animal Supplement Council) products. Your primary focus will involve providing regulatory guidance for promotional materials and labeling development, as well as supporting post-approval activities such as submissions and adverse event reporting. Your Responsibilities: Provide regulatory guidance for reviewing and approving promotional materials to support the food animal and pet health business of the Elanco US Affiliate. Fulfill ALRP (Affiliate Labeling Responsible Person) duties for post-approval label changes and collaborate with regulatory innovation for pre-approval label creation. Develop and maintain a comprehensive understanding of regulatory guidelines for EPA and NASC products. Manage all regulatory activities related to assigned products and/or areas to ensure compliance and timely submissions. Collaborate with cross-functional teams internally (Marketing, Legal, Technical, Labeling, etc.) and external partners to promote regulatory awareness and compliance. What You Need to Succeed (minimum qualifications): Education: Bachelor’s Degree or High School Diploma / GED with equivalent level of experience Required Experience: At least 3 years of relevant work experience within the sciences or related areas. Top 2 skills: Strong collaboration skills Self-management skills in an environment with diverse needs and demanding timelines What will give you a competitive edge (preferred qualifications): Understanding of the US regulatory landscape, preferably EPA and NASC regulatory requirements Strong oral and written communication skills and attention to detail Additional Information: Travel: Up to 10% annually Location: Global Elanco Headquarters - Greenfield, IN - Hybrid Work Environment (NEW HQ COMING IN 2025 - Indianapolis, IN) 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 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 matching Elanco 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 status 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™ CSR framework – all to advance the health of animals, people and the planet. Learn more at www.elanco.com.
  • 3 Days Ago

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Regulatory Affairs Technical Writer
  • Curium Pharma
  • Noblesville, IN FULL_TIME
  • About Curium Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to ...
  • 7 Days Ago

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Regulatory Affairs Officer
  • SRG
  • Edinburgh, IN FULL_TIME
  • Title: Regulatory Affairs OfficerLocation: Edinburgh area – hybrid workingType: Full-time, Permanent, 37.5 hours per week.Salary: up to £37,000 DOE SRG is working with a leading Biotechnology company ...
  • 7 Days Ago

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Regulatory Affairs Specialist - EPA
  • US01 Elanco US Inc.
  • Greenfield, IN FULL_TIME
  • 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 anima...
  • 10 Days Ago

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Regulatory Affairs Senior Specialist
  • Zimmer Biomet
  • Warsaw, IN FULL_TIME
  • At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a ...
  • 10 Days Ago

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Regulatory Affairs Associate
  • Inari
  • Lafayette, IN FULL_TIME
  • About Inari...Inari is the SEEDesign™ company. We embrace the diversity and complexity of nature in every aspect of our business to drive innovation – to push the boundaries of what is possible. Throu...
  • 11 Days Ago

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Head of Regulatory Affairs
  • Exegenesis Bio Inc
  • Ambler, PA
  • Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
  • 6/11/2024 12:00:00 AM

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Head of Regulatory Affairs
  • EPM Scientific
  • Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
  • 6/10/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/10/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 6/8/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Catalyst Life Sciences
  • Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
  • 6/8/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Kaye/Bassman International
  • San Diego, CA
  • Position Title: Head of Regulatory Affairs Location: Southern California Company Overview: We are partnered with a cutti...
  • 6/7/2024 12:00:00 AM

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Sr. Director of Regulatory Affairs - Oncology
  • Mantell Associates
  • Boston, MA
  • Mantell Associates is currently partnered with an innovative Biotech company, developing much-needed therapies for peopl...
  • 6/7/2024 12:00:00 AM

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Director of Regulatory Affairs
  • Verano
  • Chicago, IL
  • Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
  • 6/7/2024 12:00:00 AM

Indiana /ˌɪndiˈænə/ (listen) is a U.S. state located in the Midwestern and Great Lakes regions of North America. Indiana is the 38th largest by area and the 17th most populous of the 50 United States. Its capital and largest city is Indianapolis. Indiana was admitted to the United States as the 19th U.S. state on December 11, 1816. Indiana borders Lake Michigan to the northwest, Michigan to the north, Ohio to the east, Kentucky to the south and southeast, and Illinois to the west. Before becoming a territory, various indigenous peoples and Native Americans inhabited Indiana for thousands of ye...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$164,800 to $234,717

Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019