Senior Associate Promotional Regulatory Affairs

The Sr. PRA Associate 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. The Sr. PRA Associate is responsible for completing these tasks in support of the timeline identified through brand prioritization for all promotional review Assets. The Sr. PRA Process Associate works 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.
The Sr. PRA Associate is responsible 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 Veeva Promo Mats 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 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

Minimum Requirements

• Bachelors degree or equivalent experience
• Working knowledge of information/technology systems
• Strong organizational and operational skills
• Excellent interpersonal and customer relationship skills
• Excellent written and verbal communication skills

Preferred Background/Additional Skills

• 3-4 years process and/or system management experience
• Previous project management experience
• Strong problem solving skills
• Self-starter with demonstrated ability to take initiative
• Experience working in a team-based organization

Internal and External Contacts/Customers

• PRA Skill Center
• Commercial
• AZAP Asset Owners
• AZAP Asset Reviewers - PRA, Medical Information, Editorial Services
• Compliance
• ADRD Program Office
• Global Regulatory Operations
• Global Marketing Services
• Vendors and contractors

Reporting Relationship

• Direct Reports - None

• Indirect Reports - None

Why AstraZeneca?
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 groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what's next!
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
Follow AstraZeneca on Facebook - https://www.facebook.com/astrazenecacareers/
Follow AstraZeneca on Instagram - https://www.instagram.com/astrazeneca_careers/?hl=en
Date Posted
13-Nov-2023
Closing Date
14-Jan-2024
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 (e.g. race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status). 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.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.