OneTrust

Manager, Regulatory Scientist

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: San Diego • California, New Jersey, Pennsylvania • 🇺🇸 United States

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Salary

💰 $117,000 - $201,250 per year

Job Level

Mid-LevelSenior

About the role

  • Lead and/or contribute to the planning, preparation (including authoring of Regulatory documents e.g. Cover Letters, Health Authority (HA) Forms, etc.) and delivery of simple and more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
  • Partner with the NARL/GRL to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences and therapeutic area specific issues.
  • Maintain working knowledge of local regulations and submission requirements for lifecycle submissions, e.g., protocols and protocol amendments, informational amendments, annual reports, IND Safety Reports, PADERs and PSURs.
  • Manage submission delivery of all application types per market and /or region.
  • Serve as the Regulatory representative on specific multi-discipline teams, may be responsible for organizing and leading meetings.
  • Assist in strategy development by researching regulatory and medical information in preparing submissions to regional HAs.
  • Understand the regulatory framework, including regional trends, for various types of applications and procedures.
  • Review and interpret related product approval information and current HA guidances and Advisory Committee meetings.
  • Maintain up-to-date knowledge of regulations and industry environment and provide guidance on potential trends.
  • Coordinate, contribute and review the content of responses to queries from HAs for respective/regions and countries ensuring they are of high quality and submitted in accordance with timelines.

Requirements

  • A minimum of a Bachelor’s degree in a scientific or technical discipline is required.
  • Advanced degree (Master’s, PharmD, Ph.D.) in a scientific or technical discipline preferred.
  • A minimum of 4 years of relevant Regulatory Affairs experience in pharmaceutical, biotech or consumer over the counter (OTC) industry is required.
  • Understanding of FDA and International Council for Harmonization Technical Requirements for Pharmaceuticals for Human Use (ICH) regulatory requirements and guidelines, specific to the areas of clinical research, product development, and labeling, is required.
  • Knowledge of the drug product lifecycle from discovery to clinical trials to marketing is required.
  • Knowledge of Health Authority (HA) organizational structure and processes for reviewing submissions is required.
  • Experience in the Neuroscience therapeutic area is preferred.
  • Must have excellent oral and written communication skills.
  • Must have strong organization and multi-tasking skills.
  • Must have strong leadership capabilities with the ability to work successfully in a matrixed environment.
  • The ability to collaboratively influence decision-making within a cross-functional organization is required.
Benefits
  • medical
  • dental
  • vision
  • life insurance
  • short- and long-term disability
  • business accident insurance
  • group legal insurance
  • consolidated retirement plan (pension)
  • savings plan (401(k))
  • Vacation - up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays - up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Regulatory AffairsFDA regulationsICH guidelinesclinical researchproduct developmentlabelingsubmission requirementsdrug product lifecyclesubmission deliveryNeuroscience
Soft skills
oral communicationwritten communicationorganizationmulti-taskingleadershipcollaborative influencedecision-makingteamworkstrategic developmentmeeting organization
Certifications
Bachelor's degreeMaster's degreePharmDPh.D.