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Senior Process Associate, Promotional Regulatory Affairs

Ort Gaithersburg, Maryland, USA Anzeigen-ID R-083109 Veröffentlichungsdatum 06/01/2020

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.

The Senior Process Associate within Promotional Regulatory Affairs is responsible for administering the creation, approval, and submission of complete electronic FDA Form 2253 submissions to FDA in compliance with AstraZeneca Policies and Procedures, FDA Regulations, and GRPs. These tasks are completed in support of the timeline identified through brand prioritization for all promotional review Assets. You will work closely with the PRA Director, PRA Submissions Manager, PRA Skill Center members, AZAP Reviewers, and Commercial colleagues to ensure an efficient and effective compliance copy process.

Included in this role is the responsibility for reviewing incoming compliance copies to ensure AZAP submission requirements are met in accordance to related policies, guidelines, procedures. The Sr. PRA Associate also prepares and submits electronic submissions (FDA Form 2253) for Assets requiring submission to FDA.

The Sr. PRA Associate will participate in PRA Skill Center activities/projects/initiatives and may serve on internal or external project teams.

Major Responsibilities:

  • Manage the creation, approval and submission of complete electronic 2253 submissions to FDA – OPDP and APLB, including the assignment of FDA Codes as needed.
  • Review selected promotional Asset types to ensure compliance to regulatory law and guidelines in preparing promotional submissions.
  • Work collaboratively with Commercial Brand Team (s) and AZAP Review Team members in support of the brand prioritization function for compliance copy processing.
  • Manage the execution and timely delivery of AZAP VeevaPromoMats, SMRT Tool, and ANGEL/CARA related submission reports.
  • Maintain advanced expertise in importing, utilizing, and searching regulatory documents in ANGEL CARA to provide assistance to PRA Reviewers.
  • Maintain expertise in the use of SMRT Tool in the creation of submission plans.
  • Coordinate with AZAP Review Team to ensure all compliance copies for Assets are being processed in a timely and efficient manner.
  • Manage the creation and electronic submissions for Advisory Comments and communications (letters) sent to FDA via the electronic gateway.
  • Communicate with Reviewers and Asset Owners by answering questions and providing compliance copy and FDA Submission expertise.
  • Identify issues, problems or enhancements to the AZAP Approval compliance copy process.
  • Identify and share best practices with PRA to enhance efficiency and optimization of electronic compliance copy submission.
  • Maintain FDA Correspondence records and database within ANGEL CARA and PRA SharePoint.
  • If assigned, maintain PRA Nucleus Website.
  • Serve as the content expert for applicable PRA SOPs.

Essential Requirements:

  • Bachelor’s degree or 5-7 years of equivalent industry experience in lieu of degree
  • 3-4 years pharmaceutical or healthcare industry experience
  • 3-4 years process and/or system management experience
  • Working knowledge of information/technology systems
  • Strong organizational and operational skills
  • Excellent interpersonal, conflict management, and customer relationship skills
  • Excellent written and verbal communication skills

Preferred Requirements:

  • Previous project management experience
  • Strong problem-solving skills
  • Self-starter with demonstrated ability to take initiative
  • Experience working in a team-based organization

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 embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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