Regulatory Affairs Specialist jobs in Lafayette, 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.
- 16 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...
- 29 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-...
- 28 Days Ago
Student Affairs Specialist
- Purdue University
-
Lafayette, IN
OTHER
- Job Title: Student Affairs Specialist Job Description: About Our Opportunity: The Student Affairs Specialist will serve as an active member of Student Life Student Activities and Organization team wor...
- 26 Days Ago
Regulatory Consultant
- Indiana Electric Cooperatives
-
Indianapolis, IN
FULL_TIME
- Are you a goal-oriented self-starter? Do you possess good time management skills and enjoy working independently as well as working with a team? Are you organized with strong attention to detail? Does...
- 11 Days Ago
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0 Regulatory Affairs Specialist jobs found in Lafayette, IN area
LICENSED PRACTICAL NURSE - LPN - SKILLED NURSING FACILITY
- CareerStaff Unlimited
-
West Lafayette, IN
- LICENSED PRACTICAL NURSE - LPN - SKILLED NURSING FACILITY Located in West Lafayette, IN this traveler-friendly facility ...
- 4/18/2024 12:00:00 AM
LICENSED PRACTICAL NURSE - LPN - SKILLED NURSING FACILITY
- CareerStaff Unlimited
-
West Lafayette, IN
- LICENSED PRACTICAL NURSE - LPN - SKILLED NURSING FACILITY Expand your expertise as an LPN, at this highly-rated nursing ...
- 4/18/2024 12:00:00 AM
Industrial Engineer
- Ryder System
-
Lafayette, IN
- Job Seekers can review the Job Applicant Privacy Policy by clicking HERE. (https://ryder.com/job-applicant-privacy-polic...
- 4/18/2024 12:00:00 AM
Pharmacist, Arnett Hospital - Full Time/Days
- Indiana University Health
-
Lafayette, IN
- Job Description Overview This position exists to provide comprehensive, value based, medication-related care to achieve ...
- 4/18/2024 12:00:00 AM
Registered Nurse - RN - Skilled Nursing Facility (West Lafayette, IN)
- CareerStaff Unlimited
-
West Lafayette, IN
- Registered Nurse - RN - Skilled Nursing Facility Part of a larger, well-known medical system, Registered Nurses tend to ...
- 4/18/2024 12:00:00 AM
Registered Nurse - RN - Skilled Nursing Facility (West Lafayette, IN)
- CareerStaff Unlimited
-
West Lafayette, IN
- Registered Nurse - RN - Skilled Nursing Facility Part of a larger, well-known medical system, Registered Nurses tend to ...
- 4/18/2024 12:00:00 AM
Registered Nurse-Short Stay/Observation Unit- FT/N-SWO-Arnett Hospital-Relocation Incentive Available!
- Indiana University Health
-
Lafayette, IN
- Job Description Experienced RN and New Graduates Welcome to Apply! New unit with flexible start schedule!* - Relocation ...
- 4/16/2024 12:00:00 AM
Formulation Technician
- Toralgen
-
West Lafayette, IN
- Summary of Position We are seeking a highly motivated and experienced Formulation Technician to play a key role in the d...
- 4/16/2024 12:00:00 AM
About Lafayette, Indiana
Lafayette (/ˌlɑːfiːˈɛt, ˌlæf-/ LAH-fee-ET, LAF-ee-ET) is a city in and the county seat of Tippecanoe County, Indiana, United States, located 63 miles (101 km) northwest of Indianapolis and 105 miles (169 km) southeast of Chicago. West Lafayette, on the other side of the Wabash River, is home to Purdue University, which contributes significantly to both communities. Together, Lafayette and West Lafayette form the core of the Lafayette, Indiana Metropolitan Statistical Area.
According to the 2010 United States Census, the population of Lafayette was 67,140, roughly a 19% increase from 56,397 in ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$73,448 to $98,431
Lafayette, 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