Director, Global Regulatory Intelligence

24 Aug, 2021

Jobs

Director, Global Regulatory Intelligence

AstraZeneca
Gaithersburg, MD

Within Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it – working across our pipeline and the business to get medicines to patients as efficiently and effectively. We’re growing fast, and we’re as focussed and committed to the development of our people as we are our business – providing an open and supportive space to explore, learn, grow and develop across all roles and levels.

The Director, Global Regulatory Intelligence is a specialist in performing complex queries and providing highly specialized news, analysis and trends to AstraZeneca Regulatory teams globally and across all therapeutic areas, thereby enabling the development of regulatory strategies and the shaping of policy positions. Will work closely with other Regulatory Intelligence colleagues, and other closely related Intelligence functions across AstraZeneca, to provide a disease area specific Regulatory interpretation and impact analysis of emerging information. Will be recognised as a professional in global regulatory intelligence systems and tools, driving a consistent approach to their use and being responsible for their maintenance and advancement, in conjunction with IT professionals. Through training and onboarding activities, ensures regulatory colleagues globally can make the best use of intelligence tools and information resources. Contributes to the strategy, direction and efficient operation of the group.

Your Responsibilities

  • Perform bespoke Regulatory queries on behalf of regulatory project teams
  • Conducting Intelligence surveillance of external sources for communication to regulatory project teams, including specific alerts, and newsletter services
  • Maintains an archive of intelligence information for future reference
  • Contributions as required to Disease Area Landscape documents
  • Is recognized as an expert in regulatory intelligence systems and tools, driving a consistent approach to their use
  • Proactively seeks improvements with IT systems and tools, including evaluation of new commercial solutions
  • Actively engages with the Regulatory Intelligence systems and governance boards
  • Provides training, best practice knowledge sharing and onboarding activities to ensure regulatory colleagues can make best use of intelligence resources
  • Is a key partner in the review of databases, journals and other software license terms and renewals
  • Working with relevant intelligence groups across AstraZeneca and external to AstraZeneca
  • Provides support and cover for colleagues, as needed by scanning relevant websites for published calls for comments and final guidance/legislative documents; ensures the calls for comments procedures are followed and contributes to continuous improvement of the process
  • Supports maintenance of the calendar of public meetings and reports on key Health Authority events and publications
  • Has personal responsibility for crafting a culture of courageous leadership, creativity and collaboration
  • Contribute to the strategy, direction and efficient operation of the group.

Education, Qualifications, Skills and Experience (Crucial)

  • Experienced Regulatory professional with degree in a science or related field
  • Broad global understanding of intelligence and therapeutic functions relating to Regulatory Affairs
  • Detailed and in-depth knowledge of Regulatory Intelligence and TA Strategy including experience in multiple Therapeutic areas
  • Breadth of knowledge of the theories and practices of general Drug Development, with a specific understanding of AstraZeneca’s Drug Development Planning and Business information flows
  • Experience in project management
  • Excellent written and verbal communication skills
  • Leadership skills

Desirable

  • Significant Regulatory Experience across global projects and regions
  • Problem solving skills
  • Focus on delivery and results
  • Excellent strategic influencing and negotiation
  • Develops collaborative working relationships

Salary: Competitive with excellent benefits

Location: UK, Macclesfield or Cambridge

IF THIS SOUNDS LIKE THE TYPE OF ORGANISATION YOU WOULD LIKE TO GROW YOUR CAREER AND MAKE A REAL DIFFERENCE TO PATIENTS, THEN WE WOULD LOVE TO HEAR FROM YOU – APPLY TODAY!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, colour, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

 

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.

Learn more here

Job posted: 2021-08-24