at Randstad US in chicago, Illinois, United States
Job Description
regulatory affairs manager iii.
+ chicago , illinois (remote)
+ posted march 13, 2024
job details
summary
+ $75 – $82.90 per hour
+ contract
+ bachelor degree
+ category life, physical, and social science occupations
+ reference47657
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. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!
location: Chicago, Illinois
job type: Contract
salary: $75.00 – 82.90 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
+ Provides strategic and operational Regulatory CMC expertise and support in cross-functional teams, working flexibly within and across regions to provide broad operational support to ensure the delivery of project and business objectives.
+ Participates in cross-functional teams responsible for development of combination products / devices.
+ Ensures global regulatory CMC combination product / device strategy for assigned combination products are consistent with the team and business goals and meet Health Authority requirements.
+ Ensures effective communication of CMC regulatory strategy, risks, and overall plans.
+ Identifies supporting documents required for global submissions and negotiates the delivery of approved technical source documents in accordance with project timelines.
+ Prepares, authors and delivers applicable sections (IND/IMPD/CTAs/BLAs/MAAs) and full regulatory submissions (Notified Body Opinion). Responsible for submission from defining and agreeing content to leading reviews as required to ensure complete, concise and accurate submissions to Health Authorities.
+ Authors and/or review of global CMC submission responses and supporting documentation to Health Authority questions in line with agreed global regulatory strategy and timelines.
+ Provides input into Regulatory CMC risks assessment and mitigation plans and ensuring that it remains in line with the overall global Regulatory CMC strategy.
+ Participates in cross functional workstreams and initiatives, as assigned by management.
qualifications:
+ BS degree in Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science is preferred.
+ 5+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity and combination products/devices.
+ Broad background of experience gained from working in the pharmaceutical industry on development and/or post-approval activities for combination products/devices
+ Successful authoring and contribution to delivering CMC submission documents of development and/or marketed products, including experience with preparation of Notified Body Opinion submission(s) packages
+ Experience of direct communication and/or negotiation with regulatory agencies on CMC matters.
+ Knowledge of GMP requirements
skills: CMC, GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, GMP (Good Manufacturing Practice)
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.
