Job Information
Randstad US regulatory affairs ops specialist ii in round lake, Illinois
regulatory affairs ops specialist ii.
round lake , illinois
posted june 14, 2024
job details
summary
$35 - $39.40 per hour
contract
bachelor degree
category life, physical, and social science occupations
reference48309
job details
job summary:
As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A longtime partner who prides itself on being a leader in many different practical manufacturing processes to better serve the entire population is renowned for pioneering new treatments for renal diseases, immune disorders, and more; the focus is on patient care. If you're looking to be a part of an impactful team, you won't be disappointed!
This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.
location: Round Lake, Illinois
job type: Contract
salary: $35.00 - 39.40 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
Responsible for the implementation of complex global regulatory strategies, obtain and maintain marketing authorizations for product(s) and communication of general regulatory requirements in support of licensing of Company's products. Serves as a consultant to managers. Manage regulatory activities relating to specific global portfolio of products/projects.
Initiate and develop complex regulatory project plans
Identify & prioritize key areas of regulatory risk
Monitor applicable regulatory requirements
Create and maintain regulatory files in a format consistent with requirements
Provide regulatory advice to project teams.
Respond to complex questions from regulatory authorities within strict timelines
Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
Maintain and update existing regulatory authorizations
Manage regulatory activities relating to specific portfolio of products/projects
Prepare, review, and approve labeling and SOP's
Lead or represent Regulatory Affairs in project teams
Provide guidance and coaching for areas of responsibility to lower level team members
qualifications:
Bachelor's degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory experience within a pharmaceutical company for medicinal products, CRO, or similar organization. FDA regulations and knowledge
Knowledge of regulations
Scientific knowledge
Project management skills
Manage multiple projects and deadlines
Ability to multitask and prioritize
Interpersonal and communication skills
Strong negotiation skills
Technical system skills (e.g. word processing, spreadsheets, databases, online research)
Ability to work effectively in multinational/multicultural environment
Ability to identify compliance risks and escalate when necessary
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, 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).
Applications accepted on ongoing basis until filled.