Job Description
Responsibilities :
Apply below after reading through all the details and supporting information regarding this job opportunity.
Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports, and procedures, as well as any other documents determined to be within the scope of the role;
and ensure that project timelines are met.
Work cooperatively with colleagues in applicable functions or departments (e.g., R&D, Process Development, Manufacturing, Supply Chain, Regulatory Affairs, Validation, Quality Control, and Quality Assurance) and external organizations (e.
g., CMO) to ensure achievement of objectives relating to the preparation of CMC regulatory submissions and associated activities such as content verification and risk assessments.
- Experience in writing CMC components of regulatory submissions together with knowledge of relevant regulatory agency guidance including ICH, FDA, EMA, and authorities in other major geographic areas is desirable.
- Detail-oriented and articulate with the ability to write in a precise, clear style.
- Excellent communication skills, written and verbal.
- Strong team member with demonstrated ability to work collaboratively with others as well as being able to take initiative and exercise independent judgment.
- Proficient in the use of Windows environment software with advanced skills in Microsoft Word.
Additional Information
All your information will be kept confidential according to EEO guidelines.
J-18808-Ljbffr
Regulatory CMC Consultant
Perform CMC technical writing and editing assignments related to the preparation of CMC components of regulatory submissions and other technical documents such as protocols, reports, and procedures, as well as any other documents determined to be within the scope of the role; and ensure that project...
Government Accounting & Compliance Analyst
Government Accounting & Compliance Analyst. We're seeking a skilled Government Accounting & Compliance Analyst for a hybrid role based in Cambridge, MA, or Reston, VA. You'll be integral to cost accounting compliance for government contracts, regulatory review, and internal auditing....
Manager of HIV Prevention and Outreach Services
We are seeking to hire a Manager of HIV Prevention and Outreach Services at BHCHP that will be responsible for the functioning of the HIV Prevention and Screening program at the various sites of Boston Health Care for the Homeless Program and partner organizations. Over 10,000 homeless individuals a...
Regulatory Affairs Specialist
The Regulatory Affairs Specialist will be responsible for the preparation, and review of regulatory documents for a novel veterinary product in various international jurisdictions. Assist in the development of regulatory strategies to facilitate timely approvals and optimize submission processes; wo...
Regulatory Affairs Informatics Specialist
We are building a new type of regulatory intelligence platform using AI-driven workflows that enable Regulatory Affairs teams to work faster and more accurately when developing new clinical trial and regulatory filing strategies. Regulatory Affairs Informatics Specialist. We are seeking a skilled Re...
Associate Director, Regulatory Affairs CMC
Serve as a CMC strategist and project leader for projects/programs, providing regulatory assessments and developing regulatory strategies with input from the Executive Director Regulatory Affairs CMC. The Associate Director, Regulatory Chemistry Manufacturing and Control (CMC) is accountable for exe...
Senior Project Manager, Federal Programs
Senior Project Manager, Federal Programs - ( 240003ML ). As Senior Project Manager, Federal Programs, you will serve as the principal point of contact for contract and project management with the Department of Defense (DoD) and specifically Naval Facilities Engineering Systems Command (NAVFAC) Atlan...
Global Publishing Manager, Regulatory Affairs
The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning, creation, and submission of regulatory submissions. The Global Publishing Manager provides regulatory operations expertise to cross-functional submission project teams, promoting and ensuring excellence i...
Revenue Operations Manager
Hiring Manager Interview (30 min). ...
Program Manager - Hanscom
The Program Manager's primary function will be to provide comprehensive knowledge of principles, policies, and practices of systems acquisition and program management. The Program Manager shall possess the knowledge of qualitative and quantitative techniques for gathering, analyzing, and measuring t...