Regulatory Affairs CMC
Artech Information Systems LLC
Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Job Description: Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various commercial and/or development product applications. Support regulatory activities for the strategies aligned with Health Authority requirements from a global perspective, and supporting the on-time submission of regulatory submissions. Additional duties may include regulatory compliance administrative support Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites. Provide support for other CMC projects and tasks as needed. Qualifications Basic Qualification: Bachelor's degree with 2 years experience in a Regulatory Affairs related role Fluency in the understanding and format of the Common Technical Document (CTD) Authoring experience of CTD Module 2 & Module 3 sections Excellent writing skills Basic understanding of pharmaceutical manufacturing processes #J-18808-Ljbffr
Vacancy posted 4 days ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs CMC in Westborough, MA vacancy
- ...A leading IT staffing company located in Westborough, Massachusetts is seeking a Regulatory Affairs professional. The role involves performing CMC work, supporting regulatory compliance, and coordinating with various departments. Candidates should possess a bachelor's...Suggested
Artech Information System LLC
Westborough, MA4 days ago $148.5k - $214.5k
...Mass Digital Health is seeking a Regulatory Affairs CMC Project Lead to guide cross-functional pharmaceutical projects and provide strategic regulatory expertise. With a minimum of 6+ years of CMC regulatory strategy experience, you will coordinate regulatory submissions...SuggestedMass Digital Health
Framingham, MA3 days ago- ...Mass Digital Health is seeking a Global Regulatory Affairs CMC Lead to guide pharmaceutical and vaccine products through regulatory strategies. This role involves collaboration across R&D, Manufacturing, and Quality, driving success with health authorities like FDA and...Suggested
Mass Digital Health
Framingham, MA3 days ago $148.5k - $214.5k
Job title: Regulatory Affairs CMC Project Lead Location: Morristown, NJ About the job As Regulatory Affairs CMC Project Lead within our R&D team, you will serve as a strategic regulatory expert who coordinates multiple cross‑functional projects, provides senior‑level...Suggested- ...Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control... ...validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works...SuggestedWork experience placementLocal area
AbbVie
Worcester, MA8 days ago $91.15k - $123.05k
...Integrity, Innovation, Impact and Empathy. Learn more about Life at Olympus: . Job Description Assist the Manager Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus Job Duties Participate in...Full timeLocal areaWorldwideOlympus Corporation of the Americas
Westborough, MA3 days ago- ...development organizations. Candela maintains contracted distributors in over 60 other countries. General Summary The Director, Regulatory Affairs is a senior global leader responsible for defining and executing regulatory strategies that enable compliant, timely market...Worldwide
Candela Medical
Marlborough, MA4 days ago $160.5k - $305k
...Development Science and Technology (PDS&T) Biologics Analytical-CMC Strategy is responsible for driving the analytical CMC control... ...validation, advanced characterization, process development support, regulatory authoring, and control strategy for biologics. The team works...Full timeWork experience placementLocal area- ...As a Senior General Strategy Consultant, you will play a pivotal role in guiding clients through the complex landscape of regulatory affairs, ensuring compliance and facilitating the successful development and approval of pharmaceutical products. You will serve as a...Work at officeRemote workWork visaFlexible hours
Syner-G
Framingham, MA20 days ago $89.2k
Senior Regulatory Affairs Specialist We are looking to hire an enthusiastic individual for a Senior Regulatory Affairs Specialist position (hybrid work mode) supporting our rapidly growing active implantable device portfolio. This role will be responsible for Regulatory...Work at officeLocal areaRelocation3 days per week- Candela Medical is seeking a Director of Regulatory Affairs based in Marlborough, Massachusetts. This senior position is responsible for developing and executing global regulatory strategies for medical devices, managing complex regulatory challenges, and ensuring compliance...
- ...A major IT staffing firm located in Massachusetts is seeking a Regulatory Support Specialist in the single-use area of biopharmaceutical manufacturing. The role involves providing regulatory support to customers and Product Managers, as well as preparing essential documentation...Temporary work
Collabera
Westborough, MA3 days ago $102k - $220k
...about. Join us and be part of something extraordinary. We're seeking a future team member for the role of Senior Vice President, Regulatory Administration/ Filings Manager to join our Legal team, in Boston MA. This will be a 4 day in office per week position. In...Temporary workWork experience placementWork at officeWorldwideFlexible hoursBNY Mellon
Westborough, MA11 days ago- At the intersection of tech and finance. Opportunity in all directions. Find City, state, country #LIFEATBNY Connect with us: WHAT MAKES YOU UNIQUE MAKES US BETTER We understand your unique perspective leads to inventive ideas and cutting-edge approaches. This is why our...Remote workFlexible hours
BNY Mellon
Westborough, MA4 days ago - A health education institution in Shrewsbury is seeking a Disability Coordinator. This role entails reviewing and processing disability supplements, ensuring accuracy and compliance with state and federal regulations. The ideal candidate will hold an Associates Degree ...Full time
University of Massachusetts Medical School
Shrewsbury, MA4 days ago $45.12k - $74.45k
Overview The Treasury Operations Specialist provides operational support for cash management products and services within Payment Operations. This role serves as a centralized, end-to-end resource for cash management operations - handling all aspects of setup, configuration...Full timeWork experience placementRemote workMonday to FridayFlexible hoursMiddlesex Savings
Westborough, MA15 hours ago- Business/Systems Analyst A Business/Systems Analyst is required to work in Government Center area on behalf of the Client during all phases of the system development lifecycle (SDLC) to support interfaces to Client. Among other things, the System Analyst will be responsible...Work experience placement
Back Bay Staffing Group
Shrewsbury, MA1 day ago $35 - $42 per hour
.... Review incoming requests, communicate directly with requestors, and coordinate responses with internal stakeholders. Monitor regulatory deadlines and ensure timely, accurate, and compliant responses. Review documentation for completeness and confidentiality requirements...Contract workWork at office- ...Job Summary: We are seeking a skilled professional to provide critical support for import compliance, customs classification, and regulatory documentation. Our team values strong analytical ability, attention to detail, and efficient management of multiple priorities in...
SSI People
Marlborough, MA22 hours ago $33 - $40 per hour
RepliGen Corporation is seeking a Quality Control Inspector ll in Shrewsbury, Massachusetts. The successful candidate will be responsible for inspecting and reporting on incoming materials to ensure compliance with quality standards. This role involves using inspection...Hourly payRepligen
Shrewsbury, MA4 days ago- The Fountain Group is looking for a Privacy Compliance Analyst in Marlborough, MA. This role offers a hybrid schedule requiring onsite work on Tuesdays and Wednesdays. The successful candidate will support the compliance and privacy organization and manage global Data Subject...Contract workWork at office
$85k - $105k
The University of Massachusetts is hiring a Senior Benefits Generalist to oversee the administration of employee benefits and retirement plans. This role includes collaboration with HR teams and management of compliance with federal and state regulations. Located in Shrewsbury...University of Massachusetts
Shrewsbury, MA3 days ago- Assistant Restaurant Manager The Assistant Restaurant Manager supports the Restaurant Manager in their efforts to develop a team of dedicated people delivering great and friendly guest experiences and profitable top line sales. They assist in the development of Crew...Local areaShift work
Cafua Management Company, a Dunkin Franchisee
Westborough, MA4 days ago - Location: United States of America, Framingham Target start date: 01/09/2026 About the Job Operational Excellence Associate VIE within our Operational Excellence & Performance you’ll work closely with the Operational Excellence (OpEx) staff, engineers, and the compliance...Contract workWork at office
Sanofi
Northborough, MA3 days ago $162.4k
...employees, tackling some of the most important health industry challenges. About the role Boston Scientific is seeking a Global Regulatory Compliance Director, Internal Audit for its Global Quality Systems group. The purpose of this role is to provide strategic leadership...Hourly payWork at officeLocal areaShift work3 days per week$104k - $120k
Digital Federal Credit Union in Marlborough, MA, is seeking a professional for a role focused on balance sheet risk analysis. This position involves performing advanced evaluations of liquidity and interest rate risks, designing financial models, and delivering high-quality...Digital FCU
Marlborough, MA3 days ago$170.7k - $303.6k
Hologic, Inc. is seeking a Director of Post Market Compliance to ensure the effectiveness and compliance of product management systems. This role includes leading oversight of complaint handling and collaboration across global teams. The successful candidate will have ...Hologic
Marlborough, MA15 hours ago- Duration 12+ Months Description: Overview The Trade Compliance Specialist ensures compliance with U.S. Customs and other government importing regulations. They will assist in communicating and supporting operational processes related to importing requirements and Client...
$48k - $56k
The University of Massachusetts is hiring for a full-time position in the Accounts Payable department based in Westborough, MA. This role will provide clerical support, examine compliance of documents, process vendor payments, and resolve invoice issues. Ideal candidates...Full timeUniversity of Massachusetts
Westborough, MA3 days ago$86.8k - $165.2k
What You Will Do Configuration identification and configuration control. Configuration status tracking, accounting, product release and delivery. Configuration audit support: processing multiple types of documentation including engineering change notices, support program...Temporary workWork experience placementFlexible hours
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs CMC. Be the first to apply!
Related searches