Waltham, MA, USA
Posted by: Astra Zeneca
04 May
03 Jul expires

Regulatory Affairs Manager

Waltham, MA, USA
Job Description

The Regulatory Affairs Manager (RAM) is a 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.


What You'll Do?

  • 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.
  • Use and share the best methods during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
  • 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.
Job ID Reference
Desired Skills & Experience

Minimum Qualifications:

  • Bachelor's Degree in Science or related field with a minimum of 1 year 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 Qualifications:

  • Led regulatory deliverables at the project level.
  • Detailed knowledge of the drug development process.
  • Knowledge of AZ Business and processes
  Gaithersburg, Maryland, USA
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
 Waltham, MA, USA