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I thought you might be interested in the Regulatory Affairs Manager (temp / contract) job listed at Top Dog Recruiting. Just copy and paste the following link into your browser: http://topdogrecruiting.hiringhook.com/JobSeeker/Detail.aspx?jid=02483005
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Regulatory Affairs Manager (temp / contract)
$25.00 - $35.00
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Coordinate, assemble and/or prepare for submission various materials to the FDA such as ANDAs/supplements, periodic reports for approved products.
Assist VP to lead all interactions with regulatory agencies.
Point of contact to local regulatory authorities and maintain the communication system.
Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams.
To have overall responsibility for ensuring that all state regulatory requirements are addressed.
Responsible for provincial submissions in coordination with marketing.
Change control evaluation and follow up.
Identify need for new regulatory policies and implement new regulatory strategies, processes and SOPs, where applicable.
Provide current status of regulatory guidances, familiar with latest regulations, awareness of competitive performance.
Providing support to VP, RA to form networks with company senior management, updating them regularly on regulatory developments.
Ensure that the interfaces between Regulatory and other departments are managed optimally.
Bachelor's degree in Regulatory Affairs or related field required.
M.S. in Regulatory Affairs, or PharmD, preferred.
4-5 years of Regulatory Affairs experience in the pharmaceutical industry.
Demonstrates a thorough knowledge and understanding of all US FDA regulations, guidelines
Balances a sense of urgency of time pressures with adherence to all regulatory requirements
Demonstrates advanced oral and written communication skills including editing of documents prepared by others
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