Regulatory Affairs Director

at  AstraZeneca

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on!

WHAT YOU’LL DO

• Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.
• Develop and implement the program’s regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labelling that is identified by the business, markets and patients.
• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.
• Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Mentor and provide performance feedback to members of your GRST.
• Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labelling.
• Own the negotiations with health authorities and initiate and deliver key regulatory documents.
• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.
• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

ESSENTIAL FOR THE ROLE:

• An advanced degree in a science related field and/or other appropriate knowledge/experience
• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development
• Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
• Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
• The ability to think strategically and critically and evaluate risks to regulatory activities.

DESIRABLE FOR THE ROLE:

• Experience in Oncology (small molecules & biologics)
• Prior experience with phase 3 design including end of phase 2 health authority interactions
• Contribution to a regulatory approval including leading response team and labelling negotiations
• Knowledge and understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design
• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs
• Ability to work strategically within a business critical and high-profile development program
• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.