Regeneron

Compliance

• Management of US regulatory activities associated with advertising and promotion of the company’s marketed products.
• Manages commercial activities from a regulatory advertising and promotion perspective with guidance from the Regulatory Affairs, Advertising & Promotion Director.
• Creatively contribute to the advise on the development of product messages and materials across multiple functional areas.
• Provide timely regulatory advice and guidance, with guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Provide review of US and Global (if applicable) product and disease state materials/communications, with guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance.
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal.
• Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
• Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products.
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; in partnership with management, provide guidance to stakeholders with respect to impact of enforcement activities on the company policies.
• Ability to identify process improvement for promotional review activities that would enable the establishment of portfolio wide standardization of policies
• Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
• With guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Manager, Regulatory Affairs, Advertising & Promotion

• Management of US and Global (if applicable) regulatory activities associated with advertising and promotion of the company’s marketed products, as well as commercial development of pipeline products
• Manages commercial activities from a regulatory advertising and promotion perspective with minimal guidance from the Regulatory Affairs, Advertising & Promotion Director
• Creatively advise on the development of product messages and materials across multiple functional areas
• Provide timely regulatory advice and guidance, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to Commercial teams and Medical Affairs with respect to conference exhibit activities, disease awareness and speaker programs
• Provide review of US and Global (if applicable) product and disease state materials/communications, with minimal guidance from Regulatory Affairs, Advertising & Promotion Director, to support corporate goals and comply with applicable laws, regulations, and guidance
• Collaborate cross functionally with key stakeholders in areas such as Marketing, Medical Affairs, and Legal
• Responsible for establishing working relationship and managing communication with regulatory advertising and promotion professionals at co-promote partner companies
• Help lead and assist in all interactions with the FDA Office of Prescription drug Promotion (OPDP) for assigned company products, responsible for helping to maintain working relationship and effective communication with FDA OPDP reviewers with respect to advertising and promotion matters, including request for advisory submissions
• Responsible for compliance with promotional material submissions to FDA on Form 2253
• Monitor the external environment to advise product teams on evolving regulatory requirements related to product and disease state communications
• Maintain vigilance with respect to FDA promotional enforcement activities; provide stakeholders with updates on a regular basis; provide guidance to stakeholders with respect to impact of enforcement activities on the company policies
• Provide input to direct management with respect to process improvement for promotional review activities and establishment of portfolio wide standardization of policies
• Ability to cross train across products/indications to ensure continuous Regulatory A&P support is provided to stakeholders
• Collaboration with Regulatory Therapeutic Area Leads to review key marketing application summary documents and study reports
• With minimal guidance from management, help provide input during review cycles to reflect commercialization objectives and messages in the submission documents/reports that are submitted to health authorities
• Provide input to management during labeling development and negotiation to reflect commercialization objectives and messages that impact promotion and advertising.

Senior Manager, Regulatory Affairs, Advertising & Promotion

Director

• Oversee the end-to-end Issue Management framework, ensuring standardized, compliant, and inspection-ready practices
• Define and evolve Issue Management and Quality Event strategies to support scalability, efficiency, and consistency
• Drive cross-functional alignment across Quality Event Leads (QEL) and functional teams to ensure consistent and right sized approach to issue management and quality decision-making
• Lead QEL forums and provide SME guidance on QMS governance, continuous improvement, and inspection readiness
• Ensure consistency in investigations, root cause analysis, CAPAs and documentation standards
• Lead and develop line reports whilst also supporting the broader QEL community through coaching, standard setting, and knowledge sharing
• Monitor Issue Management performance through metrics and trend analysis

Associate Director – Quality Standards and Continuous Improvement

• Manage and is accountable for the PK/PD evaluation of a small portfolio of products
• Informs PMx management of important program and regulatory developments in a timely manner
• Ensures analyses and documentation are of the highest quality and accuracy
• Ensures study reports and documents have an appropriate functional review
• Solves complex problems and identifies solutions
• Makes contributions to multi-disciplinary meetings

Director, Group Quantitative Pharmacology

• Managing and mentoring a broad spectrum of individual contributing scientists
• Providing technical guidance and mentoring of colleagues
• Performance management and assessment of staff
• Developing and implementing strategic analyses in support of research and development projects
• Taking accountability for the PK/PD evaluation of a portfolio of products or projects
• Identifying opportunity for process improvements
• Solving unique and complex problems that impact the business

Senior Director, Quantitative Pharmacology

• Leading model-informed drug development strategies supporting one or more therapeutic areas across modalities including antibodies, siRNA, and gene therapies.
• Driving model-informed development (MIDD) and pharmacometrics strategies in partnership with Clinical Pharmacology, Biostatistics, Clinical and Translational teams to support regulatory and clinical decision-making.
• Leading the QP evaluation of one or more assets, accountable for timely delivery of population PK/PD, exposure–response, and translational modeling analyses.
• Representing QP at program and governance meetings, communicating quantitative insights clearly to non-modeling audiences.
• Contributing to regulatory interactions and authoring key components of regulatory documents related to QP (e.g., IB, briefing books, etc.).
• Mentoring and developing junior scientists and fostering a culture of scientific rigor and collaboration.
• Identifying and implementing process improvements, new modeling approaches, and innovative quantitative tools to enhance efficiency and impact.
• Ensuring analyses and documentation are of the highest scientific quality and regulatory compliance.

Associate Director, Quantitative Pharmacology

Sales

• recruit, train, and lead a high-performing sales team to achieve ambitious sales goals
• provide in-field coaching, feedback, and career development opportunities
• develop and implement tactical sales plans that align with national, regional, and local account strategies
• supervise and analyze sales data to identify trends and opportunities for improvement
• build and maintain positive relationships with healthcare professionals, including clinical experts in respiratory disease
• partner with internal teams and alliance collaborators to implement training programs and address market dynamics
• ensure compliance with local codes of practice while maintaining the highest ethical standards
• represent the UK sales team in international projects and cross-functional collaborations

Sales Manager, Immunology

Manager

• Develop the site start up strategy for each assigned study
• Oversee the tracking and analysis of study metrics
• Advocate for optimized site selection strategies
• Lead the development, assessment, and alignment of site activation projections
• Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF)
• Partner with cross functional and CRO partners to develop global country start up strategy
• Monitor and maintain country intelligence data
• Support regulatory submissions as needed
• Ensure timely country submission deliverables
• Lead and oversee all aspects of site start-up activities
• Serve as the subject matter expert for essential site documents
• Oversee CRO site start up management or in house site facing regional SSU team
• Represent SSU on cross-functional teams
• Recommends and drives cross functional and department process improvements
• Responsible for direct supervision of SSU staff

Senior Manager, Global Study Start Up

• Accountable for the global execution of assigned smaller or less complex clinical trials from study design through execution to study close out
• Ensures study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP
• Leads the cross-functional study team responsible for clinical study delivery
• Oversees execution against planned timelines, deliverables, and budget while raising issues to the Program Operations Lead and stakeholders
• Provides operational input into protocol development
• Conducts feasibility assessments to select relevant regions and countries
• Monitors site activation and monitoring visits and acts on deviations
• Manages study close-out activities including database lock and clinical study report writing

Manager, Clinical Study Lead

Clinical Research

• Lead in the development, evaluation, planning and execution of clinical studies
• Ensures scientific integrity and interpretation of study data of a clinical development program
• Collaborates closely with Medical Director (MD) to provide scientific expertise
• Develops/maintains proficient understanding of therapeutic disease area(s) and drug candidate
• Applies basic scientific expertise to support initiation and execution of clinical research and development studies for early and/or late-stage assets
• Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Assists with development of the Expanded Synopsis and may author clinically relevant sections

Manager, Clinical Scientist, Hematology

Product Manager

• Leading agile ceremonies, refining backlogs, and approving user stories for protocol-to-data and sample-workflow features
• Facilitating workshops with clinical, biometrics, and lab SMEs to gather requirements and prioritize improvements
• Reviewing architecture and validation plans to ensure security, privacy, and GxP compliance for API and AI components
• Supervising platform usage, data-quality dashboards, and AI guardrail metrics to drive continuous improvement
• Managing vendor results, budgets, and risks while preparing executive-ready status updates
• Coordinating change, release, and incident processes to maintain audit-ready, high-performing operations

Senior Manager, Product Management – Delivery & Operations

Risk

• Own and continuously evolve the governance framework to enable effective, scalable decision-making across the portfolio
• Establish and enforce decision quality and readiness standards, including clear articulation of options, trade-offs, risks, and recommendations
• Where required, facilitate governance forums to ensure structured, decision-focused discussions and clear, actionable outcomes
• Define and manage governance performance metrics (e.g., decision cycle time, right-first-time decisions, deferrals, forum utilization) to assess effectiveness
• Translate governance metrics and feedback into actionable insights, driving a closed-loop continuous improvement model
• Synthesize governance outputs into portfolio-level insights, identifying cross-program risks, recurring issues, and systemic bottlenecks
• Establish and maintain centralized decision documentation and knowledge management practices to ensure transparency and traceability
• Oversee governance intake, prioritization, and scheduling to ensure alignment to strategic importance, while advancing efficient, scalable processes and leveraging technology to streamline execution
• Drive cross-forum integration to streamline escalation pathways, eliminate duplication, and improve decision flow
• Partner closely with senior leaders, governance chairs, and stakeholders to align priorities and reinforce governance expectations
• Implement governance quality and experience measurement, incorporating multi-directional feedback from teams, executives, and chairs to improve effectiveness
• Coach and develop team members ensuring that the organizational strategy delivers the skills, capabilities and processes that enable portfolio delivery are present in his/her team

Director, Portfolio Governance

Financial Planning and Analysis

• Ensure compliance with financial requirements
• Maintain and develop guidelines for financial activities in Clinical Trials
• Execute financial controls in accordance with Company SOX requirements
• Partner with the Head of Program Finance for process changes/updates
• Facilitate Audit SOX annual reviews with auditors
• Provide mentorship on SOX key controls
• Perform ad-hoc reviews to detail budget control

Senior Financial Analyst

Operations

• Serves in a principal operational role for the Toxicology department
• Assists in defining standard departmental practices (including SOPs)
• Serves as the lead study monitor or sponsor representative
• Collaborates with lead scientists providing direct input on study designs and protocols
• Provides detailed evaluation of experimental data from Toxicology studies
• Assists/Directs the collection and evaluation of metrics associated with the conduct of Toxicology studies
• Provides toxicology leadership assistance in regulatory inspection readiness activities

Manager – Toxicology Operations

QA Engineer

• Guide and lead management of Good Clinical Practice Audit Strategy Programs
• Create strategic partnerships and direct risk-based audit activities
• Develop audit risk assessments and implement audit risk-based strategies
• Ensure audits are conducted in accordance with approved audit programs
• Maintain core study specific information for auditors
• Apply audit outcomes to identify quality trends and communicate compliance risks
• Represent on complex compliance projects
• Draft and issue periodic reports to management
• Provide education and/or training to Global Development departments