On behalf of our client, AstraZeneca, we are looking for a Regulatory Affairs Senior Director (RASD) consultant. Please state reference number 1030015 if you respond to this request. The assignment is for 12 months starting in January 2019.
The RASD develops and implements regulatory strategy for a group of products and ensures rapid approval. The RASD has the Global Regulatory Lead role for the product group and delivers both global regulatory strategy as well as regional leadership.
- Leads development and implementation of innovative increasingly complex global strategies to maximize the likelihood of regulatory success.
- Influences cross-functional discussions with regional/global and investigational product teams and relevant stakeholders.
- Delivers regulatory milestones (e.g., assessment of regulatory success likelihood, risk analysis, mitigation).
- Construction of the global dossier and core prescribing information.
- Maintenance and compliance activities associated with marketed products/brands.
- Serves as single point of contact and Global Regulator Affairs representative on Product Development/Global Product Teams.
- Leads the Global Regulatory Sub-team with key members from a regional perspective, emerging markets, Reg CMC, delivery & enablement.
- Partners with marketing and regional regulatory affairs staff to influence views/guidance within Health Authorities relevant topics.
- Monitors changes in regulatory environment to support and advise Global Product Teams accordingly.
- Leads cross-department/cross-functional projects on behalf of Global Regulatory Affairs as needed.
- Provides leadership in product in-license/due diligence review, divestment, and withdrawal as needed.
- Staff performance review and coaching.
- Uses external relationships with key stakeholders to reinforce AstraZeneca’s regulatory credibility.
- Provides regional focus and interacts with commercial to ensure regional commercial engagement with the proposed regulatory strategies.
- Advanced degree in a science related field and/or other appropriate knowledge/experience.
- Experience in the disease area of Respiratory, Inflammation, and Autoimmune
- A deep understanding of global regulatory science and overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
- Must have previous experience in leading Major Health Authority interactions (e.g. FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, EOP2 meetings etc.).
- At least 10 years’ experience or equivalent of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more relevant therapeutic areas.
- Broad experience working in pharmaceutical business and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority.
- Leadership and program management experience.
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Ability to work strategically within a complex and business critical development program.
- Successful contribution to a major regulatory approval at a global level.
- A scientific and clinical understanding of the regulatory sciences.
- Excellent oral and written communication skills.
- Demonstrated track record of influence, innovation, and initiative.
- any previous experience in regulatory affairs within vaccines/infectious disease is also useful.
- experience in a relevant therapy area (small molecules & biologics) is preferred. ccc
+46 737 87 57 49