Unicon Pharma Inc ยท 4 days ago
Regulatory Affairs Associate
Lake Forest, IL
Contract
Onsite
Entry, Mid Level
2+ years expUnicon Pharma Inc is a company focused on regulatory affairs, and they are seeking a Regulatory Affairs Associate to provide regulatory support and expertise for US and global submission requirements. The role involves executing global regulatory strategies, maintaining compliance of documentation for submissions, and ensuring strategic new products meet global registration requirements.
BiotechnologyMedicalPharmaceutical
Hiring Manager
Navya Matha
Responsibilities
Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations
Plans and organizes registration packages for device products. Prepares registration packages in line with regional regulatory requirements and guidelines
With oversight, understand and respond to regulatory agencies or notified body correspondences
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review
Qualification
Required
Provide regulatory support and expertise associated with US and global submission requirements, including analysis of the requirements and tracking of deliverables
With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers
Assures full regulatory compliance of all documentation for submissions and change management to enable product approval and issuance of EC certificates, FDA or other international certificates/permits/approvals
Ensure that key strategic new products are developed in line with the global registration requirements
Drives projects forward and executes agreed upon strategies and plans with oversight
Maintains awareness of applicable regulations
Plans and organizes registration packages for device products
Prepares registration packages in line with regional regulatory requirements and guidelines
With oversight, understand and respond to regulatory agencies or notified body correspondences
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations
Accurately describes these changes for ease of regulatory agency review
Proven strong understanding of FDA, EU and worldwide submission requirements
Proven strong record of preparing regulatory submissions and obtaining approvals
Identify registration documentation deficiencies and work with colleagues to accomplish resolution
Understand global regulations and assure regulatory compliance, minimizing development costs and cycles
Prepare and maintain regulatory strategy with supervision
Advanced experience with assembling global dossiers
Two to four years of medical device industry experience with regulatory affairs with direct FDA and global submission experience and authoring CE technical documentation
Strong understanding of 21 CFR 820 and ISO 13485:2016 requirements
Bachelor's Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject
A minimum of two years of experience in Medical Products Industry in Regulatory Affairs
Able to assess scientific arguments and apply analytical and logical reasonings
Ability to effectively prioritize workload and multitask with minimal supervision
Preferred
RAC Certification
Company
Unicon Pharma Inc
Unicon Pharma provides customized workforce solutions for life sciences companies, bringing innovative treatments from concept to reality.
201-500 employees
H1B Sponsorship
Unicon Pharma Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (71)
2024 (58)
2023 (71)
2022 (80)
2021 (91)
2020 (87)
Funding
Current Stage
Growth StageLeadership Team
Ravi Kollipara
CEO
Company data provided by crunchbase