Regulatory Affairs Associate II

job summary:
This is a high-impact opportunity for a Regulatory Affairs Associate II with 2+ years of experience to join a global biopharmaceutical leader in North Chicago. This role offers a 1-year initial contract with the potential for extension , operating on a hybrid schedule that brings the team together onsite Tuesday, Wednesday, and Thursday at a world-class, collaborative campus. The selection process is streamlined, beginning with an initial screen followed by a panel interview for those moving to the second round, ensuring a focused path for qualified candidates.

As a key member of the Regulatory Portfolio Management team, you won't just be tracking data-you'll be optimizing the systems that house it. This role offers the chance to lead process improvement activities and partner with global strategic planning colleagues to prevent backlogs in a truly international landscape. If you are a detail-oriented professional with a knack for software tools and a desire to influence global regulatory strategy, this is the perfect platform to elevate your career.

location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 42.18 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Execute and maintain complete regulatory planning information to ensure data readiness for leadership and cross-functional stakeholders.
• Serve as a core member of the Regulatory Portfolio Management team, assisting with the triage and disposition of system enhancement requests.
• Collaborate with Regulatory Strategic Planning colleagues to capture large datasets and proactively manage potential backlogs.
• Update and align ongoing regulatory plans with newly improved planning templates and system standards.
• Generate critical regulatory planning metrics and reports to support departmental goals and system-related needs.
• Assist in the development and delivery of system-related training materials and logistical support for global users.
• Lead or co-lead departmental process improvement activities to streamline regulatory workflows.

qualifications:

Required Skills:

• Industry Experience: Minimum of 2 years of pharmaceutical or industry-related experience.
• Matrix Environment: Proven experience working successfully within complex, matrixed organizational structures.
• Communication: Exceptional oral and written communication skills for cross-functional collaboration.
• Technical Proficiency: Demonstrated experience and understanding of various software tools and systems.
• Global Awareness: Keen awareness of cultural nuances and the ability to work effectively in a global environment.
• Soft Skills: Strong attention to detail and advanced problem-solving capabilities.

Preferred Skills:

• Subject Matter Expertise: Direct experience in Regulatory Affairs or Project Management.
• Regulatory Knowledge: Solid understanding of global pharmaceutical regulations.
• Software: Proficiency with MS Project.
• Education: Bachelor's degree.
• Certification: RAC Certification from the Regulatory Affairs Professionals Society (RAPS).
• Note: Higher education or RAC certification may compensate for years of experience; conversely, significant experience may compensate for degree requirements.

#LI-ST1?

skills: Project Management, MS-Project, Regulatory Affairs Operations, Regulatory Affairs Strategy, FDA Submissions, Regulatory Information Management (RIM), Global Regulatory Strategy Execution


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 [email protected].


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.