Sr. Director, Global Regulatory Strategy, Oncology
regulatorySomerville (MA)
$196,700.00 - $353,400.00
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Posted yesterday
regulatorySomerville (MA)
SENIORITY
Manager
SALARY
$196,700.00 - $353,400.00
About the role
The Role:
Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters. This is a newly created role intended for a forward looking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for messenger RNA therapeutics as a novel drug modality. The Sr. Director will be a strategic leader within Regulatory Affairs, 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 global regulatory strategies, highlighting risks and opportunities when appropriate, accounting for the complex interplay between major global Health Agencies, and leveraging the mRNA platform technology.
Here's What You'll Do:
- Sets strategic direction and leads the development of content, format and accountability for regulatory submissions and related supplements and amendments.
- Advises project teams regarding the development and implementation of regulatory strategy through the clinical and nonclinical development processes. Identifies potential areas of regulatory concern and responds to new government/regulatory developments.
- Establishes and maintains excellent relationships with global health agencies.
- Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly and effectively with health agencies regarding company's filings.
- 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.
- Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
- Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
- Ensures development and maintenance of the Target Label Profile and the Company Core Data Sheet for their program(s).Reviews all external materials for regulatory compliance.
- Collaborates with internal teams and Moderna partners to achieve project goals, including development content and management submissions to Health Agencies.
- Serves as overall global regulatory lead accountable for all regulatory aspects of his or her assigned project(s), including development and implementation of the global regulatory development plan for the project.
- Ensure the global regulatory strategy for assigned project(s) is consistent with the business objectives and have been negotiated with relevant health authorities as appropriate
- May be responsible for line management and development of direct reports
- Identify areas in need of improvement and lead the development and implementation of process improvements
- Manage resources for assigned project(s), including ensuring adequate regulatory resources, skills, and budgets are available to deliver the project deliverables
- Here's What You'll Bring to the Table:
- BA/BS degree in a scientific/engineering discipline 12+ years of experience in the Pharmaceutical industry 8+ years of experience in Regulatory strategy, including oncology
- Strong knowledge of current US and EU regulations, including specifically: e.g. novel regulatory pathways.
- Strong experience with CTD format and content regulatory filings
- Exceptional written and oral communication
- Experience with developing and implementing competitive regulatory strategies
- Demonstrated track record in securing product approvals and maintaining a complex portfolio
- Experience dealing with broad range of stakeholders at all levels internal and external to the company
- Demonstrated competence in employee management and development
- 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 EUDirect experience of leading regulatory authority meetings in different phases of drug development
Preferred:
Graduate degree in a scientific discipline or other relevant graduate discipline or professional certification
Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.)
Pay & Benefits:
- At Moderna, we believe that when you feel your best, you can do your best work. That's why our benefits and well-being resources are designed to support you - at work, at home, and everywhere in between.
- 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 $196,700.00 - $353,400.00. 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.Our Working ModelAs 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 leavesandaccommodations@modernatx.com.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. #LI-NH1
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