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Job Description

JOB TITLE

DEPARTMENT
LOCATION
REPORTS TO
STATUS
COMPENSATION

SENIOR MANAGER

Regulatory Affairs
Paramus NJ
Senior Director
Regular, Full-Time
Competitive

Job Summary Responsible for the regulatory operations for project development activities and assistance of project management for global clinical studies.
Essential Duties and
Responsibilities
(Include but not limited to
the following.
Other duties may be assigned)
  • Plan, implement, manage and report regulatory activities and submission timelines for global clinical studies.
  • Manage review, formatting and ensure regulatory documents to be submission ready to FDA (and HC).
  • Manage archive of IND (and CTA) publication and regulatory documents submitted to FDA (and HC).
  • Provide regulatory guidance to ensure IND, NDA and any application related communications with FDA (and HC).
  • Assist Program Manager of a development project to plan, implement, manage and report project management activities for global clinical studies.
  • Manage project development timeline and cost, and help to ensure that project activities are delivered on time and on budget.
  • Organize and facilitate meetings internally and with outside parties.
  • Research on regulatory and competitive information, including FDA guideline and announcements, press releases and scientificconferences and publications, etc.
  • Perform other task and function as required or needed.
Qualifications
  • Full functional knowledge of US regulatory requirements pertaining to the development and registration of biological or oligonucleotide-based products
  • Experience with IND and NDA filings is required
  • Working and/or in-depth knowledge of clinical and CMC aspects of regulatory affairs
  • Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, NS Pharma,Nippon Shinyaku (HQ, Japan), external      partners and vendors.
  • Strong computer skills, and proficient inMS applications (Word, Excel, PowerPoint)
  • Ability to handle multiple tasks and prioritize
  • Strong organizational, communication and presentation skills
  • Team player, flexible, ability to adapt to change
Education and/
or Experience
  • Bachelor's degree is required with a Master's degree or higher (PhD, PharmD) preferred plus appropriate level of pharmaceutical industry and regulatory affairs experience.
  • Minimum of 5 years of regulatory experience in the biotech/pharmaceutical industry; experience in the hematological malignancies, neuromuscular or orphan diseases is a plus. Practical experience with biologics and small molecules, as well as experience dealing with multiple aspects of regulatory affairs (CMC, clinical, nonclinical) is strongly preferred.