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Senior CMC Regulatory Submission Manager

Lexington, MA • On-site

Integrated Resources INC
Recruiting and Staffing Services • 51 - 200 employees
Learn more about Integrated Resources INCexternal

Contractor

Re-posted 18 days ago

Job description

Company Description

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

Position Details: 

Client Direct Client

Location Lexington, MA

Job Title Senior CMC Regulatory Submission Manager

Duration 1 Year+

Must have skill-set [Job Description] Job Summary

Under the direction of the line manager, the CMC Regulatory Submissions Manager supports the management and oversight of the CMC Regulatory Submissions for Global Portafolio of early development programs (IMPD/CTA/IND). The Regulatory Submissions Manager is also responsible for execution of the global CMC submission process (Creation, Review, Approval, Submission and Commercial Implementation of CMC Dossiers for Marketing Applications and Post- Approval) by working closely with Product Development, Regulatory, QA, GPT and MS&T crossfunctional project teams to support the execution of operational activity, monitor adherence to the process, periodically evaluate the metrics, revise the process as required, implement changes and provide appropriate training and tools. The manager will be responsible for tracking global submission activities for Biologics and Chemically Synthesized Products. In addition, the Regulatory Submissions Manager will support the global CMC Regulatory Submissions and Document Compliance department with expertise in general pharmaceutical development of global products, submission ready standards and eCTD requirements


Responsibilities: 

Knowledge of global CMC regulatory submission requirements

including submission formats (eCTD for IND, IMPD, NDA, MAAs and NEES).

Department lead on the clinical and commercial CMC submission

processes.

Tracking global submission activities. Oversees regulatory

submissions trackers

Supports the monitoring of global CMC process, evaluation of metrics periodically, monitoring the process, supports changes and provides training and tools. Maintains operational excellence of the process.

Oversees management of the content planning of regulatory

submissions within PD.

Provides guidance for submission eCTD granularity.

Maintains oversight and executes documents to submission ready

standard for CMC regulatory submissions.

Maintains global module 3 templates.

Oversees management of Quality 3D domain: Quality Folder, PD file guide, Annex 3, Submission ready standards guide.

Maintains awareness of current trends in regulatory requirements

through literature searches and networking.

Basic knowledge of US, Canadian, European regulatory requirements for APls and drug products for biologics and chemically synthesized.

Qualifications

Qualifications:


Bachelor's degree (or higher) in Chemistry, Pharmacy, Pharmaceutics, Chemical Engineering, or closely related field is desirable.


Minimum 5 years of experience in the Pharmaceutical Industry is required.


Familiarity with pharmaceutical product development, regulatory guidelines and experience in regulatory submissions (in particular CMC Module 3 information and QOS documents) throught out the development lifecycle is highly desirable.


Experience in working with the outsourcing model is preferre

Additional Information

Feel free to forward my email to your friends/colleagues who might be available

Thanks!!!

Warm Regards,

Amrit Singh

Clinical Recruiter

Integrated Resources, Inc

IT REHAB CLINICAL NURSING

Tel: (732) 429 1634  

Fax: (732) 549 5549

http://www.irionline.com

Inc. 5000 - 2007, 2008, 2009, 2010, 2011, 2012,2013 & 2014 (8th Year)

Certified MBE I GSA - Schedule 66 I GSA - Schedule 621I I GSA - Schedule 70








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About Integrated Resources

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Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.

Industry

Recruiting and staffing services

Company size

51 - 200 Employees

Headquarters location

Edison, NJ, US

Year founded

1996

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