Senior Regulatory Affairs Directors - Oncology
- Experience Level
Within Oncology Regulatory Affairs, we work in areas of unmet needs and take innovative regulatory approaches to bring life-changing treatments to those who need it - working across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. As an industry leading Oncology Regulatory function, we're growing fast and we're as focused and committed to the development of our people as we are our business - providing an open and supportive space to explore, learn, grow and develop across all roles and levels.
The Senior Regulatory Affairs Director (SRAD) serves as the Franchise Global Regulatory Lead (GRL) on complex programs with multiple indications. You will lead the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. In addition to GRL responsibilities, the SRAD has the ability to function in dual capacity by also serving as a regional lead based on their location. You will ensure that the strategy is designed to deliver rapid approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients. You'll provide team leadership and participate in coaching, and mentorship to members of the large Global Regulatory Strategy Team and will be responsible for delivery globally to contribute to the global project team's deliverables. The SRAD establishes external relationships with key regulatory stakeholders, leveraging these to maintain competitive advantage. You will be viewed as a senior leader within the regulatory community.
Typical Accountabilities, what you will be doing:
- Accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity or spanning multiple indications. This includes providing Regulatory leadership on franchise products with multiple indications and development programs. May also serve as a regional Regulatory Affairs Director (RAD) depending on location.
- Ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
- Lead a Global Regulatory Strategy Team (GRST) of other GRLs responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labelling and members of the submission and execution team. Participate in coaching, and performance feedback to members of your GRST.
- Lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.
- Represent Regulatory Affairs on Global Product Teams (GPTs) providing strategic regulatory advice and accountable for all Regulatory activities
- Accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. You will lead preparation of the regulatory strategy document and target product labelling.
- Demonstrate strategic leadership skills thereby contributing to effective product development.
- Participate in and promote novel regulatory initiatives internally, and engage externally on the corresponding topics as needed. Lead the development of novel regulatory tools and technology.
- Ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. Accountable for product maintenance, supply and compliance activities associated with marketed brands.
- Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.
Education, Qualifications, Skills and Experience:
- An advanced degree in a science related field and/or other appropriate knowledge/experience.
- Previous demonstrated experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired.
- Previous experience in leading major health authority interactions.
- Solid knowledge of regulatory affairs within several therapeutic areas in early and late development.
- Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
- Proven leadership experience.
- Ability to think strategically and critically and evaluate risks to regulatory activities.
- Deep understanding of global regulatory science and will integrate with project strategy. You have a long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
- Previous experience with FDA advisory committee and EMA oral explanation would be a plus
- Previous experience working on due diligence activities and in a business alliance environment.
- Ability to work strategically within a complex, business critical and high-profile development program.
Location: Cambridge, UK
Closing Date: 2nd March 2021
Salary: Competitive + Excellent Benefits
Next steps, if the role looks suitable to you please apply!