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Regulatory Liaison job

Ovid TherapeuticsNew York, NY
Ovid Therapeutics jobs

Company

Salary

Skills

Job Description

POSITION: Regulatory Liaison

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

* Bachelors plus Masters degrees 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
Estimated annual salary
$61,462
average
Minimum
$41,723
Maximum
$87,051

TASKS

  • Design and create special programs for tasks such as statistical analysis and data entry and cleaning.
  • Provide assistance with the preparation of project-related reports, manuscripts, and presentations.
  • Prepare tables, graphs, fact sheets, and written reports summarizing research results.
  • Perform descriptive and multivariate statistical analyses of data, using computer software.

SKILLS

  • Reading ComprehensionUnderstanding written sentences and paragraphs in work related documents.
  • Active ListeningGiving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
  • WritingCommunicating effectively in writing as appropriate for the needs of the audience.
  • SpeakingTalking to others to convey information effectively.

KNOWLEDGE

  • ClericalKnowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
  • Customer and Personal ServiceKnowledge of principles and processes for providing customer and personal services. This includes customer needs assessment, meeting quality standards for services, and evaluation of customer satisfaction.
  • Computers and ElectronicsKnowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
  • MathematicsKnowledge of arithmetic, algebra, geometry, calculus, statistics, and their applications.

Ovid Therapeutics

Type

Company - Public

Size

Small

Revenue

Less than $1M

Location

1460 BroadwayNew York, NY, 10036

Industry

Pharmaceutical/Bio-tech
Consulting/(Non-Executive) Management
Education/Training
More...

Founded

2014

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MANAGER, IT OPERATIONSOvid TherapeuticsNew York, NY
OVID Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicine® approach to develop medicines that transform the lives of patients with rare neurological disorders. We believe these disorders represent an...Read more
Sr. ParalegalOvid TherapeuticsNew York, NY
In this highly visible role, you will work in a dynamic, fast-paced environment and will have the opportunity to work independently and as part of a legal team, that provides crucial support to the company as a whole. You must be able to adapt to changing...Read more
The Associate Director, Payroll Equity & Benefits is the go to person for anything regarding payroll and the financial side of benefits administration. This Ovidian ensures that employees are paid correctly and on time and their benefits are in sync with...Read more
Executive Assistant to the Head of R&DOvid TherapeuticsNew York, NY
In this highly visible role, the Executive Assistant provides administrative support to the Head of Research & Development, as well as leaders in the R&D department.Responsibilities:Ensure that Ovid Therapeutics' s mission and values are understood and...Read more
Research Associate, NeurobiologyOvid TherapeuticsCambridge, MA
OVID Therapeutics Ovid Therapeutics Inc. is a New York-based biopharmaceutical company using its BoldMedicineA approach to develop medicines that transform the lives of patients with rare neurological disorders. We believe these disorders represent an...Read more

Closed Job Filters

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Director of Market AccessOvid TherapeuticsNew York, NY
OVERVIEW Ovid is looking for a passionate, dynamic and collaborative individual to lead global market access for our phase 2 rare epilepsy asset, soticlestat which is being co-developed with Takeda.Read more
Director of Market AccessOvid TherapeuticsNew York City, NY
OVERVIEW Ovid is looking for a passionate, dynamic and collaborative individual to lead global market access for our phase 2 rare epilepsy asset, soticlestat which is being co-developed with Takeda.Read more
PATIENT ADVOCACY MANAGEROvid TherapeuticsNew York, NY
ROLE The Patient Advocacy Manager enhances our engagement with the patient community and is key to our mission at Ovid Therapeutics to build strong relationships with the patient community. TheRead more
Patient Advocacy ManagerOvid TherapeuticsGreeley Square, NY
ROLE The Patient Advocacy Manager enhances our engagement with the patient community and is key to our mission at Ovid Therapeutics to build strong relationships with the patient community. TheRead more
Director of Market AccessOvid TherapeuticsNew York City (Manhattan), NY
OVERVIEW Ovid is looking for a passionate, dynamic and collaborative individual to lead global market access for our phase 2 rare epilepsy asset, soticlestat which is being co-developed with Takeda.Read more
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