Regulatory Affairs Specialist jobs in Indiana
Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Specialist jobs
Regulatory Affairs Specialist - EPA
- US01 Elanco US Inc.
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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.
- 2 Days Ago
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...
- 9 Days Ago
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 ...
- 9 Days Ago
Regulatory Affairs Specialist EU
- Clinglobal Group
-
Edinburgh, IN
FULL_TIME
- Regulatory Affairs Specialist - European Union Clinglobal is an Animal Health Contract Research Organisation and supports our global operations in various countries. We are currently looking for a Reg...
- 19 Days Ago
Regulatory Affairs Specialist
- Curium Pharma
-
Noblesville, IN
FULL_TIME
- Regulatory Affairs Specialist Date: May 17, 2024 Location: Noblesville, IN, United States About Curium Curium is the world's largest nuclear medicine company with more than a century of industry exper...
- 21 Days Ago
Quality Assurance and Regulatory Affairs Specialist
- Red Star
-
Larwill, IN
FULL_TIME
- SUMMARY: The position of QARA Specialist is responsible for planning, directing, and/or coordinating regulatory affairs activities of Red Star Contract Manufacturing to ensure compliance with regulati...
- 2 Months Ago
Regulatory Affairs Specialist jobs at Popular Companies
Regulatory Affairs Specialist
- GForce Life Sciences
-
Santa Clara, CA
- Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Alphatec Spine
-
Carlsbad, CA
- Primary responsibilities include the development of submissions for domestic and international clearances. Additionally,...
- 6/11/2024 12:00:00 AM
Regulatory Affairs Specialist
- Planet Pharma
-
- Immediate need for Regulatory Affairs Specialist with a Clinical Research Organization in Raleigh. Hybrid position - wil...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Astrix
-
Fort Worth, TX
- Exciting 2 year development opportunity to work for a global leader dedicated to helping people see brilliantly. The lar...
- 6/10/2024 12:00:00 AM
Regulatory Affairs Specialist
- Highridge Medical
-
Westminster, CO
- Job Summary: HIGHRIDGE creates the world’s most innovative spinal solutions across the spectrum from Motion Preservation...
- 6/9/2024 12:00:00 AM
Regulatory Affairs Specialist
- CM Medical Recruitment
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- CM Medical is seeking an experienced regulatory professional to join a fast growing team in the EP/CRM device space. In ...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Baylor College of Medicine
-
Texas City, TX
- Division: Office of Research Work Arrangement: Onsite only Location: Texas Medical Center, Houston, TX Salary Range: $54...
- 6/8/2024 12:00:00 AM
Regulatory Affairs Specialist
- Net2Source Inc.
-
Palo Alto, CA
- Job Title: Regulatory Affairs Professional 4 Duration: 12 months (Possible Extension ) Location: Palo Alto CA 94304 (Hyb...
- 6/7/2024 12:00:00 AM
About Indiana
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 Specialist jobs
$74,055 to $99,242
Most Popular Cities in Indiana for Regulatory Affairs Specialist Jobs
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Petaluma, CA
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
Regulatory Affairs Specialist in Boulder, CO
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
February 03, 2020
Regulatory Affairs Specialist in Concord, NH
Are you working as a Regulatory Affairs Specialist? Help us rate Regulatory Affairs Specialist as a Career.
December 31, 2019