As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. By working with a recruiter, you gain access to a vast network of leading employers and detailed insights into a wide range of positions. One of our premier partnerships is with a research-driven biopharmaceutical powerhouse focused on developing treatments for complex, hard-to-cure diseases. This esteemed company has brought 32 groundbreaking products to market, including Humira and Lupron, making a significant global impact. If you're ready to make your mark in the field and contribute to the future of innovative therapies, this is the opportunity for you!
location: North Chicago, Illinois
job type: Contract
salary: $35.00 - 41.49 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Prepares CMC regulatory submissions under management supervision. Prepares regulatory submissions, including new applications and amendments, renewals, annual reports, supplements, and variations under management supervision.
- Analyzes and interprets information, that impacts regulatory decisions. Seeks expert advice and technical support as required for strategies and submissions.
- Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies under management supervision.
- Responds to global regulatory information requests under management supervision and regularly informs regulatory management of important timely issues.
- Manages products and change control with an understanding of regulations and company policies and procedures under management supervision. Analyzes and approves manufacturing change requests under management supervision.
- May represent CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions Stays abreast of regulatory procedures and changes in the regulatory climate. Maintains awareness of legislation and current developments within specific area of business
qualifications:
- Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
- Preferred Education: Relevant advanced degree preferred. Certification a plus.
- Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management
- Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing
- Experience working in a complex and matrix environment
- Strong oral and written communication skills
skills: CMC, GCP (Good Clinical Practice), Regulatory Briefing Documents, Submissions, ICH Regulations
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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
