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Project Manager Of Regulatory Affairs

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Company: Select Source International Pvt

Location: Columbus, OH

Date Posted: March 19, 2014

Source: Jobma

About Company

Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering

Job Description

Position is highly visible to internal and external stakeholders. High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict. Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required. Knowledge of US and/or Canadian regulations relating to foods, infant formula ...

About Company

Select Source International is a Global Solutions provider of IT staffing and Project services. Our service offering has 5 main practices; ERP, Application Development, Middleware, Database Management and Project Services. SSI offers industry leading Data Migration, Compliance, and Risk Management through its subsidiary Data Wave. Data Wave offers Cyber Security and risk management through a GRC product suite called Risk Utilities. In addition to our technology offerings, SSI also provides administrative and business consulting services. Industry Experience: Retail Healthcare Manufacturing Energy and Utilities Government Financial Engineering

Job Description

Position is highly visible to internal and external stakeholders. High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict. Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required. Knowledge of US and/or Canadian regulations relating to foods, infant formula manufacturing, or consumer products is preferred. Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicare regulatory needs. Ability to manage and track broad and strategic projects. Ability to communicate effectively in writing crisp briefings and issue analysis. Demonstrated ability to work effectively in a team environment. Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities. Responsible for effective communication of regulatory requirements to project teams and internal customers. Responsible for representing Abbott Nutrition externally, and effectively communicating issues management to governments, trade associations, and professional societies. Accountable for compliance with internal SOPs and understanding and compliance with relevant regulations. A bachelor's degree in related field is required; A Master's degree is preferred. Two years minimum experience required. would be ideal for someone to have project management skills or ability to juggle multiple projects and organize them in a communicative manner; o would also be neat to have political science or government/government affairs/ or legal skills – not necessary but an idea of how the process for public participation works o this invidiual would help organize all regulatory authority actions in the U.S. & Canada and assist in developing the impact to Abbott for said actions, assist in leading small cross-functional teams to determine the position development for Abbott, and coordinate any strategy for response whether it be with external stakeholders or through comments to the rulemaking. o Also looking for this indidivual to help develop a strategic roadmap for the U.S./Canada group to manage the issues & strategies as aforementioned.

Keywords

Regulatory, Project management, government affairs

Recruiter Detail

Recruiter Name: Joe Thomas
Email: jthomas@selectsourceintl.com
Phone: 9525463300 ext 5015

Contact Details

Company Name: Select Source International Pvt Ltd
Company Email: xxxxxxxx@xxxx.xxx
Company Phone: xxxxxxxxxxxxxx

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