On behalf of our client, AstraZeneca, we are looking for Regulatory Affairs Director (RAD) consultants (3). Please state reference number 1030014 if you respond to this request. The assignment is for 12 months starting in January 2019.
The RAD is accountable for development and implementation of regulatory strategy for a product/group of products and ensuring the strategy leads to rapid approval. The RAD understands regional (US or EU) and/or global regulatory science and overall drug development processes.
- Leads development and implementation of innovative increasingly complex global strategies to maximize the likelihood of regulatory success.
- Influences cross-functional discussions with regional and/or Global Product Teams, Investigational Product Teams and relevant stakeholders.
- Delivery of all regulatory milestones (e.g., assessment of probability of regulatory success, risk analysis, mitigation measures).
- Planning and construction of the global dossier and core prescribing information.
- Product maintenance and compliance activities associated with marketed brands.
- Serves as the single point of contact and Global Regulator Affairs representative on Product Development Teams/Global Product Teams.
- Leads the Global Regulatory Sub-team with key contributing members from a regional perspective, emerging markets, Reg CMC as well as delivery & enablement.
- Partners with marketing and regional regulatory affairs staff to influence views/guidance within Health Authorities on specific topics of relevance.
- Monitor changes in the regulatory environment and support and advise Global Product Teams accordingly.
- Lead cross-department or cross-functional projects on behalf of Global Regulatory Affairs when necessary.
- Provide regulatory leadership in product in-license/due diligence review, divestment, and withdrawal as needed.
- Skill-development, coaching, and performance feedback for other staff working on the project.
- Advanced degree in a science related field and/or other appropriate knowledge/experience.
- Experience in the disease area of Respiratory, Inflammation, and Autoimmune
- 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.
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