Assoc. Regulatory Affairs Manager

3 weeks ago

Gaithersburg, United States Fladger Assoc. Inc. Full time
Job DescriptionJob DescriptionGaithersburg, MDContract Duration: 12-36 monthsRate: Negotiable

Responsibilities:

  • Excellent employment opportunity for a Assoc. Regulatory Affairs Manager in the Gaithersburg, MD area.
  • 100% Remote anywhere in the US - Candidate must be willing to work EST hours.
  • As a Regulatory Affairs Manager in Gaithersburg, MD, you'll play a pivotal role in channeling our Scientific capabilities to make a positive impact on changing patients' lives.
  • The Gaithersburg site offers a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center, game rooms, community garden and more to keep our employees happy and healthy.
  • Company's vision in Oncology is to help patients by redefining the cancer-treatment paradigm.
  • A broad pipeline of next-generation medicines is focused principally on four disease areas - breast, ovarian, lung and hematological cancers.
  • As well as other tumor types, these are being targeted through four key platforms - immunotherapy, the genetic drivers of cancer and resistance, DNA damage repair, and antibody drug conjugates, underpinned by personalized healthcare and biomarker technologies.
  • Regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables.
  • The RAM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more sophisticated regulatory applications and leading procedures through approval.
  • The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory input and submission delivery strategy of all dossiers and all application types per market and/or region.
  • Reviews response documents, study protocols, PSRs, among others.
  • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Lead and/or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more sophisticated submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Develop, implement and maintain submission delivery plans, content plans, and proactively provide status updates including regulatory risks and mitigation strategies to designated partners.
  • Coordinate the input, maintenance and revision in project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner.
  • Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management using the support and input of GRO, MCs, CROs and/or alliance partners.
  • Provide coaching, mentoring and knowledge sharing within the team and contribute to process improvement.

Experience:

  • Relevant BS/BA Degree in Science or related field with 1-3 years of Regulatory experience within the Biopharmaceutical industry, or at a health authority, or other confirmed experience.
  • General knowledge of Drug Development.
  • Strong Project Management skills.
  • Leadership skills, including experience leading multi-disciplinary project teams
  • Preferred skills:
    • Led regulatory deliverables at the project level.
    • Detailed knowledge of the drug development process.
    • Knowledge of company Business and processes

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