Icon hamburger
What job do you want?
Apply to this job.
Think you're the perfect candidate?
Apply Now

You’re being taken to an external site to apply.

Enter your email below to receive job recommendations for similar positions.

Regulatory Affairs Liaison/ Manager

Barrington James New York, New York Full-Time
$110,000.00 - $140,000.00 / year
Apply Now

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.



·         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.


·         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

Pre Clinical Development
Development Planning
Diseases And Disorders
Regulatory Compliance
Apply to this job.
Think you're the perfect candidate?
Apply Now

Help us improve CareerBuilder by providing feedback about this job: Report this job

Report this Job

Once a job has been reported, we will investigate it further. If you require a response, submit your question or concern to our Trust and Site Security Team


For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.

By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.