What are the responsibilities and job description for the CMC Regulatory Documentation Analyst (Remote- New Brunswick, NJ) position at Stage 4 Solutions Inc?
CMC Regulatory Documentation Analyst (Remote- New Brunswick, NJ)
We are seeking a CMC Regulatory Documentation Analyst for a global pharmaceutical client. You will be managing the documentation activities for marketing applications and / or post-approval regulatory submissions for cell therapy brands. This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and / or post-approval regulatory submissions for cell therapy brands. This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments.
This is a 40-hour per-week, 6-month contract (extensions possible), 100% remote role in New Brunswick, NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities :
Manage document preparation of CMC regulatory submission documents to BMS standards and ensure final document compliance to ensure submission content meets formatting requirements.
Manage the logistical process in the authoring system for CMC regulatory submissions.
This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling / facilitating consensus meetings, distributing review comments to the matrix teams.
Facilitate data verification to ensure the accuracy of submission data following the internal standard operating procedure. Author CMC elements of regulatory filings with supervision.
Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.
Requirements :
4 years of experience in pharmaceutical or biotechnology industry.
Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
Must have a clear understanding of CMC submission structure with respect to the different Modules (1,2,3) and respective section numbering within those modules.
Experienced in Word is required. Ability to navigate in electronic systems.
Bachelor's degree
Please submit your resume to our network at https : / / www.stage4solutions.com / careers / (please apply to the CMC Regulatory Documentation Analyst (Remote- New Brunswick, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion / belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation : $35 / hr. - $39.47hr.
LI-SW1
Salary : $35 - $39
