Regulatory Affairs Director - Oncology
Regulatory Affairs Director - Oncology
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
Oncology Regulatory Science and Strategy
Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products we work in areas of unmet need and take innovative regulatory approaches to bring lifechanging treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible.
The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.
What youll 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 programs regional or global strategy ensuring that it is crafted to deliver rapid approval with driven 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 landmarks 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.
Education Qualifications Skills and Experience
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 experience of regulatory drug development or equivalent and experience with major HA interactions.
- Demonstrated competencies of critical 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 highprofile development program
- Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.
Date Posted
09May2025Closing Date
30May2025Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion starting with our recruitment process. We welcome and consider applications from all qualified candidates regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations please complete the section in the application form.Required Experience:
Director
Employment Type
Full-Time
