PAP Executive

Typical Accountabilities:
• Supports the Global Regulatory Leader in leading the delivery of timely submissions of business priorities in compliance with relevant AstraZeneca procedures and local market regulations

• Contributes to the strategy, direction and efficient operation of the global submissions skill group by continuously enhancing the submissions organisation and operating model

• Ensures eRegulatory business needs are incorporated within AstraZeneca Regulatory systems by being involved in developing requirements, processes and standards, validating and implementing them and supporting new systems and system enhancements

• Liaises with the submission Group Managers for improved flexibility in global resource allocation by ensuring that direct reports broaden their experience within all areas of submission activity

• Identifies budget priorities taking, careful note of portfolio growth and business needs

• Serves the Global group in business projects as delegated by the Global Head Submission

• Delivers project assignments supporting the business, e.g. representation or leadership on global cross-functional task forces

• Ensure own work is compliant with all relevant AstraZeneca policies

• Proactively collects necessary information from the project team, and plans all submission management related activities

• Identifies resource needs for assigned submissions, and liaise with management to secure the required resources

• Liaises with marketing companies and regional regulatory affairs staff regarding technical and format requirements on submission deliverables

• Performs complex searches on submission life-cycle information, as required

• Shares experiences and contributes to establishing best practices


Typical People Management Responsibility (direct / indirect reports):
• Approximate number of people managed in total (all levels) - 0


What is the global remit? (how many countries will the role operate in?):
• Own country

Education, Qualifications, Skills and Experience:
• Essential: University degree or relevant similar experience; Considerable experience of drug development in the Pharmaceutical industry; ; Expertise in Information and document management technology and electronic/paper publishing software; Excellent written and verbal communication skills; Thorough knowledge of world-wide Health Authority requirements on Regulatory technical format including processes and technologies
• Desirable: Resource Management skills; Experience managing others; International work experience; Influencing and negotiating skills; Leadership skills, including proven leadership of global cross-functional project teams

Key Relationship to reach solutions:
• Internal (to AZ or team): Global Regulatory Leads; Other Research and Development functions; Operations
• External (to AZ): Health authorities; Marketing companies

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.