Detail

Salary
negotiable
Location
Gothenburg, Sweden
Posted by: Astra Zeneca
12 Aug
77 Views
11 Oct expires

Executive Regulatory Science Director

Gothenburg, Sweden
Job Description

As the Executive Regulatory Science Director, you are responsible for line managing approximately 10 Regulatory Affairs Directors (RADs). You will report directly to Vice President Regulatory CVRM. In this role, you will possess strategic leadership skills and have a deep understanding of global regulatory science, the overall drug development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders. 

 

In this role, you will:

  • partner with and mentor the Regulatory Affairs Directors (RADs) aligning on global innovative regulatory strategies for our products and ensure it is consistent with the CVRM portfolio strategy

  • provide critical review and input on disease area or portfolio regulatory strategies, risk planning and mitigations

  • ensure disease area global regulatory strategy take into account key regional considerations

  • effectively represent the regulatory function in senior level interactions at internal governance technical review committees, key global health authority meetings and external partners

  • work in collaboration with regional policy and intelligence groups to critically analyse the assessment of emerging regulatory science, data and changes in the regulatory environment and advise senior management on CVRM (product) risks/mitigation activities accordingly

  • define and drive disease area regulatory policies and priorities within CVRM with internal and external stakeholders

  • lead budget management, resource planning and recruitment of staff. In addition, provide coaching, mentoring, skill development and performance feedback to RADs as well as other (regulatory) staff

  • review and approve high-level documents for global regulatory submissions as well as core prescribing information

  • lead complex non-drug projects (cross-functional or cross-SET area) on behalf of Global Regulatory Affairs (GRA) when necessary

  • ensure submission excellence framework is timely and consistently applied across projects including sharing best submission practices and knowledge and using existing tools

Job ID Reference
1520
Desired Skills & Experience
  • Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience (Advanced degree in a scientific discipline is preferred)

  • More than 10 years drug development experience

  • Experience in global regulatory strategy and submissions that have progressed through to registration

  • Significant experience in leading major health Authority interactions

  • Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority

  • Broad experience of the Cardiovascular, Renal and Metabolism therapeutic area, with preferably specific disease area regulatory sciences expertise

  • Experience in managing people in a matrixed organizational structure

  • Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities

  • Effective judgement and decision-making in complex business critical situations

  • Excellent collaboration, team working, oral and written communication skills

  • Willingness to undertake domestic and international travel

Company
  Gaithersburg, Maryland, USA
  www.astrazeneca.com
AstraZeneca is an exciting global, innovation-driven biopharmaceutical company. We’re inspired by what science can do. Driven by the desire to meet unmet patient needs in our core therapeutic areas. Bold in our thinking. Proactive in pursuing discoveries beyond imagination. At sites across the world, we bring teams together in a spirit of collaboration to turn great ideas into life-changing medicines – strengthening our product portfolio and harnessing the potential of a pipeline across all stages of the drug development process.
You’ll be part of a team that’s rolling back the frontiers of science to turn yesterday’s impossible into the normal of tomorrow. So, if you share our focus and passion, join us and make a difference to patients – and in return, we’ll help you develop way beyond what you thought possible.
  Workplace
 Gothenburg, Sweden