Get Clinical Research JobsGet Clinical Research Jobs

Regional Regulatory Brand Manager - Submissions

Works with DRA GPT (global project team) representative to plan and facilitate presentations to Company regulatory boards on regulatory strategy
Works with DRA GPT representative to interact with regulatory consultants/advisors for global strategic input and challenge
Develops and implements regulatory readiness with other line functions, Country Pharma Organizations and key opinion leaders, and ensures integration with global regulatory readiness with DRA GPT representative
Represents DRA on sub-teams as required HA Interactions
Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative
Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents
Develops and implements plans for timely response to HA requests and coordinates responses
Leads rehearsals for HA meetings as appropriate
Implements strategy across regions in line with global strategy Identifies issues, gaps, and trade-offs affecting optimal and timely submission and approval.
Proposes options to minimize risk
Drives coordination, planning, and submission of dossiers in assigned regions worldwide
Review of global dossier summary documents
Develops and implements plans to avoid/minimize clock stops during submission review
Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs)
Reviews and submits Risk Management Plans
Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative

Excellent verbal and written skills
Knowledge of FDA regulations
Able to work effectively in a matrix team environment
At least 5 years of experience in regulatory affairs

BS in science field; Pharm D preferred

Job Closed

This position is currently filled/closed/expired, please CLICK HERE to search for similar positions.

Critical Need Jobs

Employer Information

Previous Page New Search

I appreciate having the opportunity to review the current Pharmaceutical industry positions at the Director of Clinical Research level. There is always at least one position of great interest.

Larry Hofmann, Medical Monitor

Join 3,412 other Clinical Research Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Clinical Research Jobs in New Jersey

  1. Medical Toxicologist

    Morristown, NJ
    availability for a Medical Toxicologist to join our faculty in Morristown, NJ. We are an academic department...
  2. RWJBarnabas Health seeking an Endocrinologist...

    Livingston, NJ
    Barnabas Health seeking an Endocrinologist for a private practice based in Livingston affiliated...
  3. RWJBarnabas Health Seeking Regional Director of...

    West Orange, NJ
    Cancer Center– the Director will be instrumental in linking our community programs with clinical...
  4. Clinical Research Scientist

    Florham Park, NJ
    Job Description Clinical Trial Manager will oversee and manage all operational aspects of phase I...
  5. Clinical Portfolio Specialist

    East Hanover, NJ
    for Clinical Research Associates, Regional Associate Directors, and Clinical Study Managers to...
  6. Clinical Site Manager

    East Hanover, NJ
    in clusters/countries Experience ·         Minimum 3 years’ experience in clinical research in a...
  7. In House Clinical Research Associate

    Basking Ridge, NJ
    sourced studies and studies out-sourced to Clinical Research Organizations (CROs). Responsibilities...
  8. In-House Clinical Research Associate

    Raritan, NJ
    RAVE system Responsibilities: The In-house Clinical Research Associate will work closely with the...
  9. Clinical Research Associate

    Neptune City, NJ
    visits), file maintenance, and tracking of investigator payments. Clinical Research Associate - At...
  10. In House Clinical Research Associate

    Bridgewater, NJ
    clinical research and commercialization capabilities with today’s most advanced science, business and...
Browse all Clinical Research Jobs in New Jersey
Previous Page New Search