Associate Regulatory Project Director - Gaithersburg, MD | Biospace
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Associate Regulatory Project Director

AstraZeneca Pharmaceuticals LP

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Location:
Gaithersburg, MD
Posted Date:
8/17/2017
Position Type:
Full time
Job Code:
R-011260
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Location: Gaithersburg,
Maryland,
United States
Job reference: R-011260

Posted date: Jul. 28, 2017



At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost 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 an Associate Regulatory Project Director in Gaithersburg, MD , you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.

AstraZeneca is at a critical phase in the journey to deliver our bold ambition; to improve the lives of 200 million patients and be a $50 billion company in 2025. We are on track to deliver 10 new medicines by 2020, and we have one of the most exciting portfolios in the industry.

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 experienced Associate Regulatory Project Directors (ARPD) to join our US Oncology team, for both full time and part time (20 hr per week) oppoetunities. The ARPD is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARPD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory applications and managing procedures through approval. The ARPD provides regulatory expertise and guidance on procedural and documentation requirements to Global Regulatory Execution team (GRET), Global Regulatory Strategy team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.

Accountabilities/Responsibilities:

  • Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
  • Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
    • Submission delivery strategy of all dossiers and all application types per market and/or region
    • Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, PSRs, etc.)
    • Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
  • Use and share best practices, when handling various applications and procedures 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 both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
  • Lead GRST & GRET sub-teams, i.e. Crossfunctional Submission Delivery teams for major submissions (NDA/MAA or major LCM initiative).
  • 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 communicate mitigations to Lead RPM and cross functional teams.
  • Support operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, tracking, Trial Master File, and document management utilizing the support and input of Global Regulatory Operations, Marketing Companies, Clinical Research Organizations and/or alliance partners where relevant.
  • May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
  • Provide coaching, mentoring and knowledge sharing within the RPM skill group.
  • Contribute to process improvement.

Requirements

Minimum Requirements –Education and Experience

  • Relevant University Degree in Science or related discipline.
  • Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
  • Thorough knowledge of drug development.
  • Strong project management skills.
  • Leadership skills, including experience leading multi-disciplinary project teams.

Preferred Experience

  • Experience of working in the Oncology regulatory environment in both Small and Large molecules.
  • Managed first wave Marketing Application and/or LCM submissions, in particular BLA submission experience.
  • Managed complex regulatory deliverables across projects/products.
  • Global regulatory experience.

Skills and Capabilities

  • Excellent written and verbal communication skills.
  • Cultural awareness.
  • Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions.
  • Proficiency with common project management (e.g., MS Project) and document management tools.
  • Ability to work independently and as part of a team.
  • Influencing and stakeholder management skills.
  • Ability to analyze problems and recommend actions.
  • 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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.