Actalent
Regulatory Affairs Associate I
The Regulatory Affairs Associate I is responsible for managing activities related to marketed product variations, focusing on authoring and compiling chemistry manufacturing and control (CMC) sections to ensure timely preparation of submission documents. This role involves coordinating with all functional departments to support regulatory filings.
Responsibilities
Manage and compile CMC sections of marketed product variations.
Partner with RA CMC Project Leads to develop module 3 content and project timelines.
Collaborate with diverse functional groups to ensure the file‑ability and acceptance of CMC sections.
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
Conduct review meetings for submission documents.
Understand CMC expectations, including CTD content, structural, and formatting requirements.
Maintain awareness of and utilize current best practices for regulatory business systems.
File necessary applications and handle all government interactions for regulatory approval of products.
Author and submit PMA supplements,
ఉన్న-Day Notices, Real‑Time Reviews, 180‑Day Supplements, and Annual Reports.
Review and approve engineering study protocols/reports and validation study protocols/reports.
Review and approve manufacturing changes for Class III implantable medical devices.
Essential Skills
Regulatory affairs expertise
Experience with regulatory submissions and compliance
Familiarity with regulatory documents and quality assurance
Understanding of US and international regulatory requirements for dossiers
BA/BS Degree in Chemical and/or Biological Sciences or a relevant discipline
1‑2 years of pharmaceutical experience
1‑2 years of cross‑functional project management experience
Additional Skills & Qualifications
1‑2 years of experience in regulatory affairs, R&D, or manufacturing, specifically with CTD Module 3
Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements
Knowledge of FDA PMA guidance documents and CFR regulations
Superior oral and written communication skills
Ability解绑银行卡 with global personnel
Experience with electronic document management systems
Ability to work independently and manage multiple projects simultaneously
Detail‑oriented, collaborative, and willing to learn
Work Environment The role is primarily onsite at Lake County with a hybrid work schedule from Tuesday to Thursday onsite.
Job Type & Location This is a Contract position based out of North Chicago, IL.
Pay And Benefits The pay range forSignals this position is $30.00 – $37.00 per hour. Application deadline: January 12, 2026.
Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may be subject to specific elections شك.
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&DD for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., semesters, Canada, Asia and Europe, Actalent serves many of the Fortune 500. \dup
The company is an equal‑opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
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Responsibilities
Manage and compile CMC sections of marketed product variations.
Partner with RA CMC Project Leads to develop module 3 content and project timelines.
Collaborate with diverse functional groups to ensure the file‑ability and acceptance of CMC sections.
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
Conduct review meetings for submission documents.
Understand CMC expectations, including CTD content, structural, and formatting requirements.
Maintain awareness of and utilize current best practices for regulatory business systems.
File necessary applications and handle all government interactions for regulatory approval of products.
Author and submit PMA supplements,
ఉన్న-Day Notices, Real‑Time Reviews, 180‑Day Supplements, and Annual Reports.
Review and approve engineering study protocols/reports and validation study protocols/reports.
Review and approve manufacturing changes for Class III implantable medical devices.
Essential Skills
Regulatory affairs expertise
Experience with regulatory submissions and compliance
Familiarity with regulatory documents and quality assurance
Understanding of US and international regulatory requirements for dossiers
BA/BS Degree in Chemical and/or Biological Sciences or a relevant discipline
1‑2 years of pharmaceutical experience
1‑2 years of cross‑functional project management experience
Additional Skills & Qualifications
1‑2 years of experience in regulatory affairs, R&D, or manufacturing, specifically with CTD Module 3
Proven track record of authoring, submitting, and obtaining approval for Class III implantable PMA supplements
Knowledge of FDA PMA guidance documents and CFR regulations
Superior oral and written communication skills
Ability解绑银行卡 with global personnel
Experience with electronic document management systems
Ability to work independently and manage multiple projects simultaneously
Detail‑oriented, collaborative, and willing to learn
Work Environment The role is primarily onsite at Lake County with a hybrid work schedule from Tuesday to Thursday onsite.
Job Type & Location This is a Contract position based out of North Chicago, IL.
Pay And Benefits The pay range forSignals this position is $30.00 – $37.00 per hour. Application deadline: January 12, 2026.
Eligibility requirements apply to some benefits and may depend on job classification and length of employment. Benefits are subject to change and may be subject to specific elections شك.
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&DD for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., semesters, Canada, Asia and Europe, Actalent serves many of the Fortune 500. \dup
The company is an equal‑opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
#J-18808-Ljbffr