Regulatory Affairs Specialist jobs in Greenwood, IN
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.
-
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 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 equivalent. 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.
- 14 Days Ago
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...
- 1 Month Ago
Regulatory Affairs Manager
- Sonablate Corp.
-
Indianapolis, IN
FULL_TIME
- Job OverviewThe Regulatory Affairs Manager provides regulatory leadership to the Company, ensuring that Sonablate Corp. continues to meet its Quality Policy and Objectives. This role involves the deve...
- 27 Days Ago
Specialist, Product Regulatory Services
- Calumet Specialty Products Partners L.P.
-
Indianapolis, IN
FULL_TIME
- Specialist, Product Regulatory Services Indianapolis, IN, USA Req #1389 Friday, January 12, 2024 Who are we? At Calumet we deliver innovative specialty products trusted by companies across the globe. ...
- 5 Days Ago
Specialist, Product Regulatory Services
- calumet
-
Indianapolis, IN
FULL_TIME
- Who are we? At Calumet we deliver innovative specialty products trusted by companies across the globe. We are the foundation to everyday essential products that help millions of people live and thrive...
- 6 Days Ago
Quality & Regulatory Compliance Specialist
- ALOM Technologies
-
Indianapolis, IN
FULL_TIME
- Are you a quality-focused professional who excels in leading a team in a high-volume manufacturing environment? Are you looking to be an integral part of a top-performing division within a technology-...
- 26 Days Ago
Filters
- Current Active Filter
- Greenwood, IN
Clear All
- Filter Jobs By posted time
- Within 1 Day
- Within 2-7
- Within 1 Month
- Within 3 Months
0 Regulatory Affairs Specialist jobs found in Greenwood, IN area
Director of Professional Services (DOPS)/Branch Director - Hiring Now!
- Hiring Now!
-
Greenwood, IN
- Intrepid USA - Our vision makes a difference: We are a top 10 national home healthcare company with an overall 50 year h...
- 4/15/2024 12:00:00 AM
Sr. Associate/ Assistant Manager-Trade Finance Controls
- BNP Paribas Bank NV
-
Greenwood, IN
- We are looking for **Sr. Associate/ Assistant Manager-Trade Finance Controls** **Level of experience** **Location** **Ab...
- 4/14/2024 12:00:00 AM
Customer Support Specialist-Point of Care Diagnostics (remote/hybrid)
- PTS Diagnostics
-
Greenwood, IN
- Job Description Job Description Are you a quick learner with the ability to gain technical knowledge to support medical ...
- 4/14/2024 12:00:00 AM
Director of Clinical Excellence RN / LPN
- Hiring Now!
-
Greenwood, IN
- The Director of Clinical Excellence RN / LPN Develops, implements, and maintains a facility-wide infection prevention an...
- 4/13/2024 12:00:00 AM
Financial Representative - Carmel, IN
- Fidelity TalentSource LLC
-
Carmel, IN
- Job Description: Financial Representative We believe that as a Financial Representative, you make a key impact on the br...
- 4/12/2024 12:00:00 AM
Regulatory Affairs Specialist - EPA
- Elanco Animal Health Incorporated
-
Indianapolis, IN
- At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation...
- 4/12/2024 12:00:00 AM
IT Compliance And Risk Management Analyst - REMOTE
- Javen Technologies
-
Columbus, IN
- Must Haves: * Black Kite Vendor Risk Monitoring * Black Kite Cyber Risk Alerts Review * Venminder and Venmonitor Risk Re...
- 4/12/2024 12:00:00 AM
Senior Associate / Assistant Manager - RISK ORC ISPL
- BNP Paribas Bank NV
-
Greenwood, IN
- We are looking for **Senior Associate / Assistant Manager - RISK ORC ISPL** **Level of experience** **Location** **About...
- 4/12/2024 12:00:00 AM
About Greenwood, Indiana
Greenwood is a city in Johnson County, Indiana, United States. The population was 49,791 at the 2010 Census, and increased to 56,545 in the Census 2016 estimates. Greenwood is located between Indiana State Road 37 and Interstate 65. The city shares a border with Indianapolis and is the most populous suburb in the southern portion of the Indianapolis Metropolitan Area....
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,903 to $99,042
Greenwood, Indiana area prices
were up 1.3% from a year ago
were up 1.3% from a year ago
What does a Regulatory Affairs Specialist do?
Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
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