This Regulatory Affairs Associate I position offers a dynamic opportunity for a detail-oriented professional to make a significant impact on both pharmaceutical and medical device regulatory lifecycles. Based in North Chicago with a flexible hybrid schedule, you will play a pivotal role in managing and authoring CMC (Chemistry, Manufacturing, and Controls) Module 3 content for marketed products, while also gaining high-level exposure to Class III implantable medical devices. This role is designed for a proactive communicator who thrives on cross-functional collaboration and is ready to lead project meetings and navigate complex ICH and FDA (CFR) regulations. If you possess a scientific background and are eager to apply your expertise in PMA supplements and electronic document management systems within a fast-paced, global environment, this 6-month contract provides an ideal platform to advance your regulatory career.
location: North Chicago, Illinois
job type: Contract
salary: $35 - 40 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Responsible for managing and compiling CMC sections of marketed product variations.
- Partner with RA CMC Project Leads and develop module 3 content and project timelines.
- Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Skills for running review meetings for submission documents.
- Understand CMC expectations including CTD content, structural and formatting requirements.
- Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports.
- Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 1-3 years of direct experience in the field.
- Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks.
- May lead and direct the work of others. A wide degree of creativity and latitude is expected.
- Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
- Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
- Independently facilitate project team meetings.
- Superior oral and written communication skills
- Ability to work cooperatively with all levels and types of global personnel required
- Experience working with electronic document management systems
- Ability to work independently. Manage multiple projects simultaneously.
- Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies as necessary.
- Detail/accuracy oriented, collaborative and willing to learn
- Familiarity with US and other international regulatory requirements for dossiers
qualifications:
Required:
- Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
- Required Experience: 1-2 years of pharmaceutical experience and 1-2 years of cross functional project management experience
- CMC portion of Module 3 (drug substance, drug products)
- ICH and 4Q requirements - 1-5 structures and what they are
- General medical device experience
- 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
- Analytical Process background
- Prior experience with Cosmos
skills: Regulatory Affairs Strategy, Regulatory Compliance, Regulatory Audit Preparation, Common Technical Document (CTD), Chemistry Manufacturing and Controls (CMC), Electronic Common Technical Document (eCTD), Internal Regulatory Audits
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
