Regulatory Project Manager
Location:
Gaithersburg , Maryland
Posted:
November 23, 2017
Reference:
R-016924
Regulatory Project Manager - Gaithersburg, MD
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe. As a Regulatory Project Manager in Gaithersburg, MD, you'll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients' lives. GMD (Global Medicines Development) drives late-stage development of our innovative pipeline, transforming exciting science into valued new medicines and ensuring patients around the world can access them.
AstraZeneca's strategy in CVMD focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk factors across cardiovascular (CV) disease, diabetes and chronic kidney-disease indications. The patient-centric approach is reinforced by science-led life-cycle management programmes and technologies, including early research into regenerative methods.
The Regulatory Project Management group sits within the AZ Global Regulatory Affairs, Patient Safety and QA (GRAPSQA) organization and is accountable for end to end regulatory project delivery, providing regulatory expertise, efficient project management and strong leadership in line with business priorities.
We are now looking to recruit a Regulatory Project Manager for a position within RPM CVMD & NS team in Gaithersburg. The Regulatory Project Manager (RPM) is a regulatory specialist with project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The RPM contributes to regulatory submission strategy, identifying submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval. The RPM provides regulatory expertise and guidance on procedural and documentation requirements to GRET (Global Regulatory Execution Team), GRST (Global Regulatory Strategy Team), and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Main Duties and Responsibilities
In this role you will be responsible for monitoring and interpreting the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions. You will provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).  In addition you will use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work. You will lead and / or contribute to the planning, preparation and delivery of simple and with experience, increasingly more complex submissions throughout the product's life cycle from either a global and/or regional perspective. You will be responsible for developing, executing and maintaining submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders. You will coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager. You will identify regulatory risks and propose mitigations to Lead RPM and cross functional teams. You will also support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, Trial Master File (TMF), and document management utilizing the support and input of Global Regulatory Operations , marketing Companies, Contract Resource Organizations and/or alliance partners where relevant. In this role you will provide coaching, mentoring and knowledge sharing within the RPM skill group. Finally, you will contribute to process improvement.
Accountabilities/Responsibilities:
  • Monitor and interpret the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory input on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s).
  • Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work.
  • Lead and / or contribute to the planning, preparation and delivery of simple and with experience, increasingly more complex submissions throughout the product's life cycle from either a global and/or regional perspective.
  • Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
  • Coordinate the input, maintenance and revision in the OPAL project plans for assigned projects, and highlight unforeseen changes in resource demand in a timely manner to Lead RPM and line manager.
  • Identify regulatory risks and propose mitigations to Lead RPM and cross functional teams.
  • Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, Trial Master File (TMF), and document management utilizing the support and input of Global Regulatory Operations , marketing Companies, Contract Resource Organizations and/or alliance partners where relevant.
  • Provide coaching, mentoring and knowledge sharing within the RPM skill group.
  • Contribute to process improvement.
Essential Requirements
  • Relevant University Degree in Science or related discipline
  • Minimum one year of regulatory experience
  • General knowledge of the drug development process
  • Strong project management skills
  • Leadership skills, including experience leading multi-disciplinary project teams
  • Knowledge of AZ Business and processes
  • Excellent written and verbal communication skills
  • Influencing and stakeholder management skills
  • Continuous Improvement and knowledge sharing focused
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

A little about us:
At AstraZeneca, we believe the best way we can help patients is to focus on breakthrough science in order to uncover disease mechanisms and develop novel, targeted therapies that interact with them. This is at the heart of our purpose as a company: to push the boundaries of science to deliver life-changing medicines.

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