The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
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The Position The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality ...
Quality & Regulatory Intern
$13.75 - $18.50/hr
An intern can expect to virtually and/or in-person meet with associates, vendors, customers to ... Percentage Position Functions 50% Quality * key quality assurance (QA)/regulatory affairs (RA ...
Quality & Regulatory Intern
$13.75 - $18.50/hr
An intern can expect to virtually and/or in-person meet with associates, vendors, customers to ... Percentage Position Functions 50% Quality * key quality assurance (QA)/regulatory affairs (RA ...
Quality & Regulatory Intern
Prairie Du Sac, WI · On-site
$13.75 - $18.50/hr
An intern can expect to virtually and/or in-person meet with associates, vendors, customers to ... Percentage Position Functions 50% Quality * key quality assurance (QA)/regulatory affairs (RA ...
Quality & Regulatory Intern
Prairie Du Sac, WI · On-site
$13.75 - $18.50/hr
An intern can expect to virtually and/or in-person meet with associates, vendors, customers to ... Percentage Position Functions 50% Quality * key quality assurance (QA)/regulatory affairs (RA ...
Patent Litigation and Regulatory Compliance Manager
Cottage Grove, WI · On-site
Medical
Dental
Vision
Life
Retirement
PTO
POSITION OVERVIEW Under the direction of the Patent & Advanced Mechanics Manager, the Patent Litigation and Regulatory Compliance Manager will take a leadership role in protecting and defending the ...
Patent Litigation and Regulatory Compliance Manager
Cottage Grove, WI · On-site
Medical
Dental
Vision
Life
Retirement
PTO
POSITION OVERVIEW Under the direction of the Patent & Advanced Mechanics Manager, the Patent Litigation and Regulatory Compliance Manager will take a leadership role in protecting and defending the ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 1st Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Warehouse Associate - 3rd Shift
Madison, WI · On-site
$16 - $19.25/hr
Medical
Dental
Vision
Life
Retirement
PTO
Must adhere to all safety regulations, including the correct usage of personal protective equipment ... our associates. Our competitive offering not only includes benefits like health, dental, vision ...
Regulatory Associate information
See Madison, WI salary details
$17.20 - $20.10
12% of jobs
$20.10 - $23.01
6% of jobs
$24.66 is the 25th percentile. Wages below this are outliers.
$23.01 - $25.92
12% of jobs
$25.92 - $28.82
12% of jobs
The median wage is $31 / hr.
$28.82 - $31.73
11% of jobs
$31.73 - $34.64
14% of jobs
$37.45 is the 75th percentile. Wages above this are outliers.
$34.64 - $37.54
9% of jobs
$37.54 - $40.45
11% of jobs
$40.45 - $43.36
3% of jobs
$43.36 - $46.26
5% of jobs
$46.26 - $49.17
5% of jobs
$17
$32
$49
How much do regulatory associate jobs pay per hour?
What does a regulatory associate do?
As a regulatory associate or regulatory affairs associate, your job is to coordinate compliance with internal—and occasionally external—regulations. This work involves checking each inspection review for accuracy, using safety data sheets (SDS), gathering and compiling documentation for products, and submitting material for license renewals and registrations. In this role, you often create management templates, study existing report documents, oversee the collection of consent forms, and audit the company for any sign of regulatory noncompliance. Some regulatory associates frequently travel to perform audits at various locations. Depending on the industry, you may have additional tasks that involve meeting state or federal guidelines.
Is regulatory associate high paying?
What is the difference between Regulatory Associate vs Compliance Specialist?
| Aspect | Regulatory Associate | Compliance Specialist |
|---|---|---|
| Required Credentials | Bachelor's degree in life sciences, regulatory affairs, or related field; certifications like RAC are a plus | Bachelor's degree in law, business, or related; certifications like CCEP may be relevant |
| Work Environment | Pharmaceutical, biotech, or medical device companies; regulatory departments | Corporate compliance departments across various industries, including healthcare and finance |
| Employer & Industry Usage | Used in regulated industries to prepare and submit regulatory documents | Used to ensure company adherence to laws and regulations, often involving audits and policy development |
The Regulatory Associate primarily focuses on preparing and managing regulatory submissions within life sciences industries, while the Compliance Specialist ensures ongoing adherence to laws and regulations across various sectors. Both roles require similar educational backgrounds and certifications, but their core responsibilities and work environments differ slightly, with Regulatory Associates working more directly with regulatory agencies and Compliance Specialists focusing on internal compliance processes.
What are some common challenges regulatory associates face when working with cross-functional teams?
What are the key skills and qualifications needed to thrive as a regulatory associate, and why are they important?

Full-time
Posted 8 days ago
Job description
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The Senior Associate, Regulatory CMC supports the execution of regulatory change control and post-approval lifecycle management activities. This role evaluates manufacturing and quality-related changes, assesses potential regulatory impact, and supports the preparation and coordination of regulatory submissions in accordance with global health authority requirements.
The Senior Associate applies scientific, risk-based principles, including relevant concepts outlined in ICH Q12, to support efficient and compliant post-approval change management. Working closely with Regulatory CMC, Quality, Manufacturing, Supply Chain, and external partners, this position helps ensure that CMC changes are appropriately evaluated, documented, communicated, and implemented.
The ideal candidate has practical Regulatory CMC experience, a working knowledge of global health authority requirements, and the ability to manage assigned activities with limited oversight while appropriately escalating significant issues.
This is a full-time, onsite position at Arrowhead's site in Verona, WI.
Responsibilities
- Manage assigned post-approval change control activities, including reviewing change records, assessing potential regulatory impact, and supporting related regulatory submissions.
- Evaluate manufacturing, analytical, quality, and supply-related changes against applicable global regulatory requirements and existing product registrations.
- Apply scientific and risk-based approaches, including relevant ICH Q12 principles, when assessing post-approval changes.
- Prepare and maintain clear regulatory assessments, documentation, submission content, and implementation requirements.
- Support the preparation and coordination of global post-approval submissions, including variations, amendments, supplements, notifications, and annual reportable changes.
- Identify opportunities to appropriately group or bundle related changes for review by senior Regulatory CMC colleagues.
- Provide regulatory change control support to internal manufacturing sites, external manufacturing partners, and suppliers across small-molecule and biologic products.
- Collaborate with Quality, Manufacturing, Supply Chain, Technical Operations, and external partners to obtain the information needed to complete regulatory assessments.
- Communicate regulatory requirements, submission commitments, and implementation conditions to relevant stakeholders.
- Participate in cross-functional change review meetings and represent Regulatory CMC for assigned products or change records.
- Support alignment between product CMC teams and global Regulatory CMC regarding post-approval strategies, submission requirements, and implementation timelines.
- Maintain accurate regulatory information within applicable systems, including Veeva Registrations or other regulatory information management platforms.
- Track assigned activities and communicate potential risks, delays, or compliance concerns to management in a timely manner.
- Contribute to process improvements that increase the efficiency, consistency, and quality of regulatory change control activities.
- Stay current on relevant global regulations, guidance, and regulatory intelligence related to CMC lifecycle management.
Requirements
- Bachelor's degree in a scientific, engineering, regulatory, or related discipline.
- Three to five years of relevant experience in the biopharmaceutical, pharmaceutical, or medical device industry.
- At least three years of direct Regulatory CMC experience.
- Experience supporting post-approval lifecycle management activities, such as variations, amendments, supplements, annual reports, or other CMC-related submissions.
- Experience contributing to a major variation or amendment, or supporting an initial NDA or BLA, is preferred.
- Working knowledge of global health authority requirements and regulatory expectations related to CMC development and post-approval lifecycle management.
- Understanding of scientific principles and regulatory CMC requirements relevant to drug development, registration, manufacturing, and post-market support.
- Experience with regulatory information management or CMC lifecycle management systems, such as Veeva Registrations.
- Ability to analyze regulatory and technical information with strong attention to detail.
- Ability to evaluate alternative approaches, identify potential risks, and recommend solutions for review by more senior team members.
- Ability to manage assigned responsibilities with limited oversight and appropriately escalate significant or time-sensitive issues.
- Sound judgment and an understanding of decision-making responsibilities and escalation pathways.
- Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines.
- Demonstrated problem-solving ability, flexibility, accountability, and commitment to teamwork.
- Strong written and verbal communication skills.
- Ability to build effective working relationships and collaborate across functions, sites, and external partners.
Preferred
- Master's degree or other advanced degree in a scientific, engineering, regulatory, or related discipline.
- Experience supporting both small-molecule and biologic products.
- Familiarity with ICH Q12 and other guidance related to pharmaceutical product lifecycle management.
- Experience working with global manufacturing sites, contract manufacturing organizations, or external suppliers.
- Experience using Veeva Registrations or a comparable regulatory information management system.
- Familiarity with regulatory intelligence research and the application of regulatory precedents.
Wisconsin pay range
$90,000-$125,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
Candidates must have current, valid authorization to work in the country where this role is located.
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About Arrowhead Pharmaceuticals
Sourced by ZipRecruiter
Industry
Pharmaceutical and medicine manufacturing
Company size
201 - 500 Employees
Headquarters location
Pasadena, CA, US
Year founded
1989