The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation of the global regulatory strategy for CGT products of high complexity and visibility and may serve as Franchise GRL on complex programs with multiple indications.

In addition to GRL responsibilities, the Sr RAD has the ability to function in dual capacity by also serving as a regional lead based on their location.

The Sr RAD ensures that the regulatory strategy is designed to deliver efficient approval with competitive labelling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.

The Sr RAD provides team leadership and participates in coaching and mentorship to members of the relevant CGT Global Regulatory Strategy Team and is responsible for leading the global regulatory deliverables in line with GPT goals.

The Sr RAD establishes external relationships with key Regulatory stakeholders, leveraging these to maintain competitive advantage.

They are viewed as a Senior Leader within the Regulatory Community.

Key Responsibilities:

• Lead and own the development and implementation of the global regulatory strategy for a CGT product of high complexity, from current stage through BLA submission.

• May serve in dual-role as GRL and regional RAD.

• As a core member of the global product team, ensure that regulatory strategies are designed to deliver an efficient path to approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients, and contribute to governance presentations.

• Lead regulatory strategy for all health authority meetings, responses to information requests, BLA development and submission, expedited pathway designations.

• Maintain a strong working knowledge of the relevant disease areas: early- and late-stage multiple myeloma.

• Lead a Global Regulatory Strategy Team (GRST) responsible for specific indications/programs within the franchise, key contributing members from the regions, emerging markets, RA CMC, Labeling 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 project-related regulatory milestones, including assessment of the probability of regulatory success and mitigations.

• You will lead preparation of the regulatory strategy document and target product labeling.

• Demonstrate strategic, leadership, and collaboration skills, contributing to effective cross-functional teamwork in product development.

• Lead, participate, and promote non-project functional or cross-functional initiatives 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 and compliance activities associated with marketed brands.

• Partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

• May have line management responsibilities in addition to matrixed supervisory, leadership, and mentoring roles.

Education, Qualifications, Skills and Experience

Essential:

• An advanced degree in a science related field and seven-ten years of experience and/or appropriate knowledge/experience.

• Demonstrated success in cell and/or gene therapy regulatory strategy.

• Deep understanding of global regulatory science and integration with program strategy.

• Long standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.

• Experience with product development for multiple myeloma.

• Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs.

• Experience in Oncology (small molecules & biologics) is preferred.

• Proven experience leading regulatory and cross-functional teams, and stakeholder management.

• Ability to think strategically and critically and evaluate risks to regulatory activities.

• Previous experience in leading major Health Authority interactions.

• Excellent oral, written, and presentation skills.

• Strong organizational skills.

• Ability to work in a fast-paced environment in a hands-on fashion.

• Flexible and proactive, with the ability to manage multiple projects and successfully adapt to changing business needs and priorities.

Desirable:

• Successful leadership of at least one global regulatory approval including leading response team and labeling negotiations

• Experience with FDA advisory committee and EMA oral explanation .

• Experience developing products for the treatment of autoimmune conditions.

• Experience working on due diligence activities and in a business alliance environment.

• Experience in leading and growing people through coaching or mentorship.

• Contribution to non-project business initiatives (e.g. at a portfolio or cross functional level)

About AstraZeneca

At AstraZeneca, Regulatory professionals help turn breakthrough science into real solutions for patients with serious diseases by shaping innovative pathways through complex global requirements.

Working with colleagues across locations, therapy areas and external partners, this role offers the chance to influence strategy end-to-end, from early development through rapid global approvals, while learning from leading experts, sharing best practices and using data, technology and modern approaches to reduce barriers for patients worldwide.

If this opportunity to drive transformative cell and gene therapies towards approval resonates, apply now to join us in bringing life-changing medicines to those who need them most.

Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week.

The annual base salary for this position ranges from $218,058.40 - 327,087.60. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.

In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles).

Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Date Posted 10-Apr-2026 Closing Date 29-Apr-2026 Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants without regard to race, color, religion, gender, sexual orientation, gender identity, age, disability, marital status, citizenship, national origin, or veteran status.

XML job scraping automation by YubHub

Your responsibilities will include developing monitoring techniques and observability methods, researching mechanisms for layered control, and designing red-team simulations to probe weaknesses in oversight and control mechanisms.

To succeed in this role, you'll need a strong background in machine learning, particularly in generative AI, and at least three years of experience addressing sophisticated ML problems. You should be comfortable designing control and monitoring experiments for AI systems, building prototype systems, and quickly turning new ideas from the research literature into working prototypes.

In addition to your technical expertise, you'll need strong written and verbal communication skills to operate in a cross-functional team.

This role offers a competitive salary range of $216,000-$270,000 USD, depending on location and experience, as well as equity-based compensation and benefits, including comprehensive health, dental, and vision coverage, retirement benefits, a learning and development stipend, and generous PTO.

XML job scraping automation by YubHub

In this role, you will leverage your expertise in credit risk assessment and analysis, including financial statement analysis, credit risk modeling, covenant analysis, leverage and coverage ratio calculations, industry and company research, cash flow analysis, debt capacity assessments, credit memo preparation, counterparty risk evaluation, rating methodologies, credit monitoring, and risk mitigation strategies to support the training of AI systems.

You will collaborate with technical teams to refine annotation tools and curate impactful data, ensuring our models effectively capture real-world private credit analysis dynamics.

This role requires adaptability, strong analytical skills, and a passion for driving innovation in a fast-paced environment.

Responsibilities:

• Utilize proprietary software to provide accurate input and labels for private credit projects, ensuring high-quality data for AI model training.
• Deliver curated, high-quality data for scenarios involving financial statement analysis, credit risk assessment, covenant compliance evaluation, debt capacity modeling, industry benchmarking, cash flow projections, rating analysis, and credit monitoring activities.
• Collaborate with technical staff to support the training of new AI tasks and contribute to the development of innovative technologies.
• Assist in designing and improving efficient annotation tools tailored for credit analysis data.
• Select and analyze complex problems in credit analysis aligned with your expertise to enhance AI model performance.
• Interpret, analyze, and execute tasks based on evolving instructions, maintaining precision and adaptability.

Basic Qualifications:

• Professional experience in credit analysis or related fields (e.g., credit analyst, underwriter, or risk professional at commercial banks, investment banks, rating agencies, insurance companies, or corporate credit departments).
• Proficiency in reading and writing informal and professional English.
• Strong communication, interpersonal, analytical, and organizational skills.
• Excellent reading comprehension and ability to exercise autonomous judgment with limited data.
• Passion for technological advancements and innovation in credit analysis.

Preferred Skills and Experience:

• Relevant certification or advanced training (e.g., CFA, FRM, CRC or similar finance-related certification).
• Experience mentoring or training others in private credit practices, such as credit underwriting, loan structuring, covenant analysis, or portfolio monitoring.
• Comfort with recording audio or video sessions for data collection.
• Familiarity with AI or data annotation workflows in a technical setting.

Location and Other Expectations:

• Tutor roles may be offered as full-time, part-time, or contractor positions, depending on role needs and candidate fit.
• For contractor positions, hours will vary widely based on project scope and contractor availability, with no fixed commitments required. On average most projects may involve at least 10 hours per week to achieve deliverables effectively though this is not a fixed commitment and depends on the scope of work. Contractors have full flexibility to set their own hours and determine the exact amount of time needed to complete deliverables.
• Tutor roles may be performed remotely from any location worldwide, subject to legal eligibility, time-zone compatibility, and role specific needs.
• For US based candidates, please note we are unable to hire in the states of Wyoming and Illinois at this time.
• We are unable to provide visa sponsorship.
• For those who will be working from a personal device, your computer must be a Chromebook, Mac with MacOS 11.0 or later, or Windows 10 or later.

Compensation and Benefits:

US based candidates: $45/hour - $100/hour depending on factors including relevant experience, skills, education, geographic location, and qualifications. International candidates: Information will be provided to you during the recruitment process.

Benefits vary based on employment type, location and jurisdiction. Benefits for eligible U.S. based positions include health insurance, 401(k) plan, and paid sick leave. Specific details and role specific information will be provided to you during the interview process.

XML job scraping automation by YubHub

With particular focus on crypto/stablecoin workstream, you will be responsible for:

• Partnering deeply with GTM and business teams during the pre-sales cycle for complex Crypto/Stablecoin prospects.
• Acting as a specialised advisor for high-stakes or complex user negotiations.
• Working with users and internal teams to architect flows that meet compliance obligations while minimizing friction.
• Conducting risk-based reviews of non-standard crypto business models.
• Aggregating insights from user interactions to identify where our policies or products can be enhanced.

This role requires a compliance expert who is fluent in both crypto regulations and commercial reality. You will need to be comfortable straddling the worlds of technology and finance every day, moving quickly in the face of ambiguity to help scale our crypto/stablecoin business globally.

We are looking for someone with 5+ years of experience in financial crimes compliance, with significant time spent specifically in the crypto and stablecoin space. You should have experience evaluating complex user requests for compliance risk and working with business stakeholders to implement creative solutions to enable users while meeting compliance requirements.

XML job scraping automation by YubHub

At OpenAI, our User Operations team safeguards our products and users from legal risk, regulatory non-compliance, fraud, and abuse. The team operates at the intersection of operations, compliance, and user trust, embedded within the broader User Operations organization and collaborating cross-functionally with Legal, Policy, Engineering, Product, and external vendors.

We support a global and diverse user base across OpenAI’s suite of products ChatGPT, SORA, API, Enterprise offerings, and developer tools by managing sensitive inbound tickets, regulatory obligations, and fraud-related escalations. Every user-facing action is grounded in our commitment to legal integrity, ethical practice, and regulatory excellence.

About the Role

We are seeking a sharp, adaptive, and operations-minded Regulatory Operations Analyst to help scale and evolve OpenAI’s global compliance support infrastructure.

In this role, you will own high-sensitivity workflows involving complex global regulatory escalations, trust and safety matters, privacy rights requests, and intellectual property matters. You’ll serve as both a frontline operator and strategic partner, triaging and resolving complex cases while also shaping the systems, documentation, and processes that support OpenAI’s regulatory and compliance goals. You will contribute as a subject-matter expert (SME) on high-stakes escalations, partnering with cross-functional stakeholders to drive fast, defensible outcomes. You will also help design the processes, tooling, and automation that power safe operations at scale.

This role is essential to building scalable, high-integrity operations that protect user rights, meet our obligations under emerging and current regulations, and reduce OpenAI’s risk exposure. You’ll also contribute to multi-phase transitions and automation efforts that support our long-term operational model.

We use a hybrid work model of 3 days in the office per week in our Dublin office.

_Please note: This role may involve exposure to sensitive or concerning content, including complaints involving harassment, fraud, or regulatory violations. Strong personal discretion, empathy, and resilience are essential._

In This Role, You Will:

• Handle and resolve complex user issues involving:

• Trust & Safety incidents

• Regulatory, audit, or compliance inquiries and complaints

• Intellectual property matters (e.g., copyright takedowns, ownership disputes)

• AI governance and regulatory frameworks (e.g., EU AI Act, DSA/OSA)
• Perform risk evaluations and investigations using internal tools, documentation, and third-party data

• Act as incident manager for highly sensitive reviews requiring nuanced interpretation of legal and regulatory standards

• Interface directly with Legal, Privacy, Product, and Support teams to coordinate escalations and resolution paths

• Partner with Legal, Privacy, Policy, and Ops to implement world-class operational workflows for compliance and risk

• Build and maintain tooling, escalation decision trees, playbooks, and knowledge articles

• Contribute to vendor training and governance models, especially during transitions and ramp-up phases

• Lead or participate in cross-functional initiatives that strengthen our regulatory, fraud, and legal infrastructure

• Monitor operational health via case quality audits, SLA tracking, escalation accuracy, and data

You Might Thrive in This Role If You:

• Have 5+ years of experience in legal operations, regulatory compliance, or trust & safety especially in a global or high-growth tech environment

• Have partnered with in-house counsel, DPOs, or external regulators on audits or escalations

• Understand tiered support structures and have worked with vendor operations at scale

• Bring a structured, systems-first mindset to operational governance and risk evaluation

• Communicate clearly, empathetically, and effectively especially in writing responses to sensitive issues

• Operate well in ambiguity and can manage multiple priorities simultaneously with speed and precision

Thrive in high-autonomy environments and hold a high bar for ownership and integrity

About OpenAI

OpenAI is an AI research and deployment company dedicated to ensuring that general-purpose artificial intelligence benefits all of humanity. We push the boundaries of the capabilities of AI systems and seek to safely deploy them to the world through our products. AI is an extremely powerful tool that must be created with safety and human needs at its core, and to achieve our mission, we must encompass and value the many different perspectives, voices, and experiences that form the full spectrum of humanity.

XML job scraping automation by YubHub