AstraZeneca Pharmaceuticals LP Associate Director, Regulatory Information Team in Gaithersburg, Maryland

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 an Assocaite Director, Regulatory Information Team in Gaithersburg, MD, you’ll play a pivotal role in channeling 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.

The Associate Director, Regulatory Information Team will be responsible for maintaining and developing regulatory information management (RIM) within AstraZeneca. Responsibilities include enabling and driving efficient management of the regulatory information with regards to AZ licenses and submissions worldwide and overseeing regulatory information quality and reporting.

Typical Accountabilities

  • Lead strategy implementation efforts to ensure oversight of RIM system compliance

  • Drive business value and efficiency in the management and delivery of regulatory information.

  • Interpret xEVMPD/ISO IDMP data governance, business readiness, and process frameworks

  • Partner with individual system and information owners within Regulatory, IT and associated organizations to ensure the overall strategy for RIM is advanced in alignment with AZ corporate scorecard and other initiatives.

  • Engage with IT and other RIM stakeholders (internal AZ business functions) and vendors to influence health authority and industry innovation.

  • Enable and facilitate collaboration with all business units creating regulatory information across the entire value chain, from development through marketing, maintenance and pharmacovigilance.

  • Lead or participates as a member of Global Regulatory Operations (GRO) and/or cross-functional change teams, providing expert advice.

  • Liase with regulatory tracking governance bodies/organizations within AstraZeneca

  • Lead process development efforts, continuous improvement activities, and engage with organizational bodies related to RIM procedural documents, toolkits and other guidance to ensure that regulatory information is communicated and understood by broader cross functional teams.

  • Create harmonization to influence the information flow and collaboration between the RIM business and IT stakeholders

Education, Qualifications, Skills and Experience

Essential

  • 5+ years of Regulatory Affairs experience

  • Strong process mapping and authoring skills

  • Experience in implementing regulatory systems

  • Experience in Regulatory information management/GxP data

  • Experience in XEVMPD/ISO IDMP

  • Strong Stakeholder Management skills

  • Experience in project management, managing project timelines and resources

  • Detail focused and the ability to manage complex, multiple projects

  • Experience with working in high pressure environments and teams where sensitivity to priorities needs to be handled whilst still delivering against strategic objectives

  • Excellent analytical skills

  • Strong social skills with the ability to collaborate with people on different levels, in sometimes sensitive areas.

Desirable

  • Manages change with a positive approach to the challenges of change for self, indirect team members, and the business. Sees change as an opportunity to improve performance and add value to the business.

  • Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills.

  • Good problem and conflict resolution skills.

  • Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment.

  • Ability to innovate best practice with business process analysis and design

  • Ability to thrive in a rapid paced environment

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.