Rangam · 2 days ago
RCI-ABBV-31993 CMC Regulatory Affairs Associate (eCTD Module 3)
United States
Contract
Remote
Entry, Mid Level
$36/hr - $38/hr
1+ years expRangam is seeking a CMC Regulatory Affairs Associate to manage the activities for marketed product variations. The role involves authoring and compiling CMC sections to ensure timely preparation of submission documents while coordinating with functional departments in support of regulatory filings.
ConsultingInformation TechnologySoftwareStaffing Agency
Hiring Manager
Sumit Rawat
Responsibilities
Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines
Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Skills for running review meetings for submission documents
Understand CMC expectations including CTD content, structural and formatting requirements
Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval
Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports)
Review/approval of engineering study protocols/reports and validation study protocols/reports
Review and approval of manufacturing changes for Class III implantable medical devices
May require an advanced degree and 1-3 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations
Relies on extensive experience and judgment to plan and accomplish goals
Performs a variety of tasks. May lead and direct the work of others
A wide degree of creativity and latitude is expected
Qualification
Required
Must have a good communication skills
ICH M4Q exp
Must have CTD/eCTD exp
Must have prior CMC exp
Minimum educational qualification: BS/MS
Manager is looking for someone who can manage CMC
Must have exp. with Module-3 on a CMC content
Must have exp. with ICH module guidelines
Manager is looking for 1-2 years of experience level within a regulated industry
This position would be involve in Dossier preparation
Deal Breaking skills: CMC, Module-3, & CTD/eCTD content
Must have prior pharma industry exp
Only med device would not work, the candidate have to have CMC and M-3 exp
Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
Required Experience: 1-2 years pharmaceutical. 1-2 years cross functional project management
Preferred
Prior exp. with Technical Files would be a plus
Master's degree with internship kind of exp. would be considerable (But manager sounds like doubtful)
Prior global exp. would be nice to have but not a deal breaker
Prior medical device industry exp. would nice to have
Prior analytical and process chemistry exp. would be helpful
Experience working with electronic document management systems
Familiarity with US and other international regulatory requirements for dossiers
Preferred Experience: 1-2 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3)
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
501-1000 employees
H1B Sponsorship
Rangam 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 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageLeadership Team
Nish Parikh
Co-founder & CEO
Hetal Parikh
Co-Founder & President
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