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Regulatory Affairs Liaison/ Manager

Barrington James New York, New York Full-Time
$110,000.00 - $140,000.00 / year
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The Regulatory Liaison will be a Regulatory member of our core development team. He/she will be

mentored by senior regulatory professionals to become proficient in the interactions with US and RoW

health authorities and working in cross-functional development teams.

 

RESPONSIBILITIES

·         Assist in development of global regulatory strategies to ensure high likelihood of success of submissions/approvals

·         Help liaise and assist with global regulatory authorities to manage day-to-day communications and operations

·         Contribute to the clinical development plans and regulatory strategic plans, to the project team

·         Assist the preparation of regulatory submissions including pre-IND and formal meeting requests with FDA, Annual reports and routine correspondence

·         Assist in the planning, coordination and preparation for meetings and teleconferences with regulatory authorities

·         Monitor and oversees clinical trial activities for regulatory compliance and practices

·         Assist in providing regulatory intelligence for cross-functional project teams

·         Assist in regulatory review, feedback and /or approval for relevant documents.

 

·         Provide regulatory support and guidance to cross-functional project teams for regulatory issues and questions and ensure that regulatory requirements are addressed

·         Interact with company partners and consultants for various regulatory matters as needed

·         Coordinate timely submissions to FDA and other health authorities

·         Assist with logging, tracking and filing of correspondence and submission to/from regulatory authorities

·         Prepare and writes regulatory documents for submissions

·         Monitor applicable current and new regulatory requirements

·         Help to prepare plan and internal SOP’s to manage regulatory compliance and reporting requirements.

REQUIREMENTS

·         B.Sc or M.Sc. in relevant field and at least 3 years of overall experience in the pharmaceutical industry. Advanced degree (PhD, PharmD) is a plus.

·         Good working knowledge of FDA regulatory requirements and IND applications, experience in Pharmacovigilance is a plus

·         Experience with multiple Health Authorities (FDA, EMA, PMDA) interactions and Scientific Advice proceedings

·         Ability to assume accountability for a project goal/objective

·         Experience working in cross-functional teams, participating in team discussions to resolve and reach agreement on project issues

·         Excellent written and oral communication skills

·         Knowledge in CNS disease area and Orphan Diseases is preferred

·         Travel: Approximately 10% domestic and international travel for meetings with health authorities and conferences

Recommended skills

Pharmacovigilance
Pre Clinical Development
Development Planning
Diseases And Disorders
Regulatory Compliance
Communication
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