Regulatory Affairs Manager
Lexington, MA · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Develop regulatory submission strategies in agreement with defined product development objectives.

Lexington, MA · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Develop regulatory submission strategies in agreement with defined product development objectives.
Lexington, MA · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Develop regulatory submission strategies in agreement with defined product development objectives.
East Windsor, NJ · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Familiar with adapting QbD (Quality by Design) elements in generic product development.
East Windsor, NJ · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Familiar with adapting QbD (Quality by Design) elements in generic product development.
Rochester, NY · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... product development and transfer of knowledge. Provides technical input as appropriate. Ensures ...
Rochester, NY · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... product development and transfer of knowledge. Provides technical input as appropriate. Ensures ...
Rochester, NY · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Performsspecialized tasknulls that contribute to product development/testing. Focusis on ...
Rochester, NY · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Performsspecialized tasknulls that contribute to product development/testing. Focusis on ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Assessing feasibility and development of new IVD reagents. Investigate and develop new methods and ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Assessing feasibility and development of new IVD reagents. Investigate and develop new methods and ...
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Provide regulatory support, guidance and expertise to internal groups such as product development ...
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Provide regulatory support, guidance and expertise to internal groups such as product development ...
Baltimore, MD · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Scientist will support technology and product development projects with their technical knowledge.
Baltimore, MD · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Scientist will support technology and product development projects with their technical knowledge.
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Leading development of product line extensions, gap fill projects and all improvement projects ...
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Leading development of product line extensions, gap fill projects and all improvement projects ...
Ashburn, VA · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Work with Dev teams, PMs, product owners to develop and execute, acceptance and E2E test plans.
Ashburn, VA · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Work with Dev teams, PMs, product owners to develop and execute, acceptance and E2E test plans.
North Haven, CT · On-site
$19 - $25/hr
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Product Development process. *****Mechanical or Biomedical Engineer is preferred. Will consider ...
North Haven, CT · On-site
$19 - $25/hr
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Product Development process. *****Mechanical or Biomedical Engineer is preferred. Will consider ...
Memphis, TN · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... product development. Responsibilities: Recruit, select, manage, and develop a high performing ...
Memphis, TN · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... product development. Responsibilities: Recruit, select, manage, and develop a high performing ...
Jacksonville, FL · On-site
$96K - $127K/yr
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... of product development experience in New Product Development or Released Product Engineering.
Jacksonville, FL · On-site
$96K - $127K/yr
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... of product development experience in New Product Development or Released Product Engineering.
Cincinnati, OH · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Performing research & testing which support development of products or procedures. Under guidance ...
Cincinnati, OH · On-site
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... Performing research & testing which support development of products or procedures. Under guidance ...
$96K - $127K/yr
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... of product development experience in New Product Development or Released Product Engineering.
$96K - $127K/yr
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... of product development experience in New Product Development or Released Product Engineering.
Company Description INTEGRATED RESOURCES STAFFING PVT LTD Job title: Regulatory Affairs Specialist ... product development teams, familiarity with FDA regulations for medical devices, submission ...
Company Description INTEGRATED RESOURCES STAFFING PVT LTD Job title: Regulatory Affairs Specialist ... product development teams, familiarity with FDA regulations for medical devices, submission ...
Exton, PA · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Production support environment Configure business processes Ability to do workday EIB's (mass ...
Exton, PA · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Production support environment Configure business processes Ability to do workday EIB's (mass ...
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... This HRBP will provide support to the Business Operations Team (R&D, Product Management, Corporate ...
Company Description A Few Words About Us Integrated Resources, Inc is a premier staffing firm ... This HRBP will provide support to the Business Operations Team (R&D, Product Management, Corporate ...
Madison, WI · On-site
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We ... of product development lifecycles, design change and document change control, process verification ...
Madison, WI · On-site
Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We ... of product development lifecycles, design change and document change control, process verification ...
Topeka, KS · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... We need people with 5-10 years of experience and having experience with annuity product development ...
Topeka, KS · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... We need people with 5-10 years of experience and having experience with annuity product development ...
Raleigh, NC · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Responsible for supporting the NC R&D group, to include recruiting, new hire onboarding, employee ...
Raleigh, NC · On-site
Company Description Integrated Resources, Inc is a premier staffing firm recognized as one of the ... Responsible for supporting the NC R&D group, to include recruiting, new hire onboarding, employee ...
What makes Integrated Resources an attractive place to work?

Contractor
Re-posted 13 days ago
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.
Client Direct Client
Location Lexington, MA
Job Title Regulatory Affairs Manager
Duration 6+ Months
Must have skill-set [Job Description] Job Function and Description:
Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products.
Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development.
Develop regulatory submission strategies in agreement with defined product development objectives. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects.
Prepare and submit IND and NDA applications, as well as various amendments and supplements.
Prior management experience, with a demonstrated capability to lead and motivate staff is essential.
Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical. Experience Requirements:
Minimum of 5 years + experience in drug development and registration activities, including personal management of an approved new drug from initial development through to approval and market launch.
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
Sourced by ZipRecruiter
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.
Recruiting and staffing services
51 - 200 Employees
Edison, NJ, US
1996