Director, Global Regulatory Strategy, Oncology

The Role: Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in developing and gaining market approval for messenger RNA products in the U.S. and other markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing regulatory plans for assigned programs, and as an expert within Regulatory, will be relied on to articulate clear and compelling regulatory strategy, highlighting risks and opportunities when appropriate. Prior regulatory experience with therapeutics development is preferred. Here’s What You’ll Do: Serve as global regulatory lead accountable for all regulatory aspects of his or her assigned program(s), including development and implementation of the global regulatory strategy plan for the program Represent Regulatory Science on cross-functional program teams Ensure the global regulatory strategy for assigned program(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the Global Regulatory Science Leadership Team, Project Development Team and senior management, as relevant Collaborates with internal teams and Moderna partners as relevant to achieve program goals, including development content and management of submissions to Health Agencies Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related amendments Monitors regulatory developments related to mRNA platform and advises program teams regarding the development and implementation of regulatory strategy through the clinical development processes Conducts risks and gaps assessment and identifies potential areas of regulatory concern and responds to new government/regulatory developments Establishes and maintains excellent relationships with regulatory agency personnel Negotiates directly and effectively with health agencies regarding company's filings Responds to requests for additional data, organizes and manages participation in meetings Reviews and approves technical data and verifies accuracy of clinical data and execution of clinical projects to regulatory authorities Develops, implements, and reviews current policies and practices in compliance with Federal and international regulatory agencies Monitors regulatory intelligence and publications to keep apprised of new or changing regulatory developments and potential strategic impact Serves as regulatory science representative to provide input on trials and filing activities and to ensure that report systems are maintained and compliant Supports development and maintenance of the Target Label Profile and the Company Core Data Sheet Identifies areas in need of improvement and lead the development and implementation of process improvements Manages resources for assigned program(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the program deliverables Here’s What You’ll Bring to the Table: BA/BS degree in a scientific/engineering discipline required. PharmD, Masters or PhD preferred. 10+ years of experience in the Pharmaceutical industry. 8+ years of experience in Regulatory strategy. Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology programs. Strong experience with CTD format and content regulatory filings. Experience with developing and implementing competitive regulatory strategies. Demonstrated track record in securing product approvals and maintaining a complex portfolio is preferred. Knowledge of and broad experience with regulatory procedures and legislation for drug development, product registration, line extension and license maintenance – preferably from at least both US and EU. Direct experience of leading regulatory authority meetings in different phases of drug development. Regulatory knowledge across therapeutic areas including Oncology development is preferable. Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.). Ability to work independently to manage multiple programs in a fast-paced environment. Ability to collaborate effectively in a dynamic, cross-functional matrix environment to drive meeting each program’s critical regulatory milestones. Partners with internal teams and Moderna partners to develop content and manage submissions to regulatory bodies. Effectively communicate the regulatory strategy, risks, mitigations and overall plans to Regulatory Science, the Project Team and senior management, as relevant. Identify areas in need of improvement and lead the development and implementation of process improvements. Outstanding communication skills (verbal and written) and willingness to share knowledge and lessons learned. Pay & Benefits Competitive healthcare, plus voluntary benefit programs to support your unique needs. A holistic approach to well-being, with access to fitness, mindfulness, and mental health support. Family planning benefits, including fertility, adoption, and surrogacy support. Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown. Savings and investments to help you plan for the future. Location-specific perks and extras. The salary range for this role is $167,000.00 - $300,700.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs. The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance. About Moderna Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities. We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S. If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities. Our Working Model As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact. Moderna is a smoke-free, alcohol-free, and drug-free work environment. Equal Opportunities Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements. Accommodations We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best. Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at View email address on click.appcast.io. Export Control Notice This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant’s ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license. Our Mission and Vision At Moderna we are pioneering the development of a new class of drugs made of messenger RNA (mRNA). This novel drug platform builds on the discovery that modified mRNA can direct the body’s cellular machinery to produce nearly any protein of interest, from native proteins to antibodies and other entirely novel protein constructs that can have therapeutic activity inside and outside of cells. We have a clear mission to propel the field of mRNA science forward and deliver new medicines to patients and a unique vision for how to achieve this mission. Our Mission: To deliver on the promise of transformative messenger RNA (mRNA) science to bring new medicines to patients. Our Vision: To unlock the potential of mRNA by establishing an ecosystem of teams and partners that will work together to develop the broadest possible array of drugs, across diverse therapeutic areas and routes of administration, for serious diseases that are not treatable today. #J-18808-Ljbffr Moderna Therapeutics