Sr. Manager, GRS Integration

Moderna Therapeutics; Cambridge (MA); Ibrido; USD 131.000 - 209.000; Tempo pieno

Vantaggi offerti da questo lavoro

Healthcare benefits

Voluntary benefits

Well-being programs

Family planning benefits

Paid time off

Savings & investments

Location-specific perks

Descrizione del lavoro

Moderna Therapeutics is seeking a Senior Manager, GRS Integration to support multiple development and commercial programs within Global Regulatory Science. You will translate regulatory strategy into coordinated plans, manage milestones, and partner across GRLs, Country Regulatory Leads, and CMC teams to ensure timely submissions and regulatory commitments.

You will lead planning discussions, manage trackers and dashboards, and proactively identify risks while driving cross-program enhancements

Competenze

• BA/BS in a scientific, engineering, healthcare, business, or related discipline.
• Minimum of 5 years of progressive experience in pharma/biotech or life sciences.
• Experience in regulatory planning, submissions, and lifecycle management.
• Ability to coordinate across multiple stakeholders in a matrix organization.
• Strong project management, organizational, and facilitation skills.

Mansioni

• Develop, maintain, and execute integrated regulatory plans with GRLs and cross-functional partners.
• Translate regulatory strategy into actionable plans, milestones, and timelines.
• Manage regulatory plans, trackers, dashboards, and planning tools for visibility.
• Facilitate regulatory team meetings and ensure decisions and actions are tracked.
• Identify risks and dependencies; develop mitigation plans and scenario planning.
• Support regulatory activities including submissions and health authority interactions.
• Contribute to continuous improvement of GRS Integration processes.

Conoscenze

Project management

Regulatory planning

Cross-functional collaboration

Risk management

Communication & influencing

Prioritization & workflow management

Formazione

BA/BS in scientific/engineering/healthcare/business

Advanced degree or PM certification preferred

Descrizione del lavoro

The Role: Moderna is seeking a Senior Manager, GRS Integration to support assigned development and/or marketed programs within Global Regulatory Science. This role may support more than one program at a time based on business priorities, program needs, and team capacity. The Senior Manager, GRS Integration will work closely with Global Regulatory Leads (GRLs), Country Regulatory Leads, Regulatory CMC Leads, and other regulatory and cross-functional partners to support the planning, coordination, and execution of regulatory activities across assigned programs. The role is responsible for helping translate regulatory strategy and program priorities into coordinated plans, timelines, milestones, and deliverables, while maintaining visibility to dependencies, risks, and upcoming regulatory commitments. This role requires strong project and program management capabilities, effective partnership, sound judgment, and the ability to manage multiple priorities in a matrixed environment. The Senior Manager will actively manage regulatory plans and activities in partnership with program regulatory leadership, helping ensure that teams remain aligned, actions are followed through, risks are surfaced appropriately, and regulatory milestones progress as planned. Here’s What You’ll Do:

• Support one or more assigned programs, partnering closely with Global Regulatory Leads, Country Regulatory Leads, Regulatory CMC Leads, and other regulatory team members to develop, maintain, and execute integrated regulatory plans.
• Translate agreed regulatory strategy and program priorities into actionable plans, milestones, deliverables, timelines, dependencies, and ownership, ensuring regulatory activities remain coordinated across development, registration, and post-marketing stages.
• Actively manage regulatory plans, trackers, dashboards, and related planning tools to maintain current and accurate visibility into program milestones, risks, deliverables, dependencies, and upcoming decision points.
• Facilitate regulatory team meetings and planning discussions, ensuring decisions, risks, actions, and follow-up activities are clearly captured, assigned, and progressed.
• Proactively identify timeline risks, gaps, dependencies, and operational challenges; partner with regulatory leads to assess impacts, develop mitigation plans, support scenario planning, and elevate issues when appropriate.
• Support planning and readiness for major regulatory activities, including submissions, health authority interactions, responses to questions, CMC regulatory activities and variations, and country-specific regulatory requirements.
• Contribute to continuous improvement and cross-program initiatives that strengthen GRS Integration processes, tools, data quality, planning practices, visibility, and operational consistency.

Here’s What You’ll Bring to the Table:

• BA/BS degree in a scientific, engineering, healthcare, business, or related discipline required; advanced degree and/or project management certification is a plus.
• Minimum of 5 years of progressive experience in the pharmaceutical, biotechnology, or related life sciences industry, with relevant experience in regulatory project/program management, regulatory operations, drug development, or a closely related function.
• Experience supporting regulatory planning and execution across one or more stages of product development, registration, and/or post-marketing activities.
• Understanding of regulatory development processes and the activities required to support regulatory submissions, health authority interactions, approvals, and ongoing regulatory commitments.
• Knowledge of U.S. regulatory requirements with exposure to international regulatory requirements and global development activities.
• Demonstrated ability to coordinate complex deliverables, timelines, and dependencies across multiple stakeholders in a matrixed organization.
• Experience supporting regulatory submissions and familiarity with regulatory documentation and eCTD submission processes.
• Ability to manage more than one program or workstream at a time while maintaining appropriate prioritization, organization, and follow-through.
• Strong project management, organizational, and facilitation skills.
• Effective communication and influencing skills, with the ability to work collaboratively with Global Regulatory Leads, Country Regulatory Leads, Regulatory CMC Leads, and cross‑functional stakeholders.
• Demonstrated ability to identify risks and issues, seek appropriate guidance, elevate when needed, and drive agreed actions to completion.
• Ability to operate effectively in a dynamic environment with changing priorities, evolving program needs, and competing timelines.
• Strong proficiency with project management, planning, and collaboration tools and an interest in using technology to improve regulatory planning, visibility, and execution.
• A collaborative, accountable, and continuous‑improvement mindset, with the ability to work independently where appropriate while recognizing when alignment, guidance, or escalation is needed.

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.

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 $130,800.00 - $209,400.00. 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. 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.

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 [e-mail].

Reasonable Accommodation Notice

Moderna will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Applicants with disabilities may be entitled to reasonable accommodation under the terms of the Americans with Disabilities Act and certain state or local laws. Please inform the company's personnel representative by calling 617-460-9346 or emailing [e-mail] if you need assistance completing any forms or to otherwise participate in the application process. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.

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

• 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.

Third Party Staffing Agencies

Moderna does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Moderna from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Moderna and do not obligate Moderna to pay fees if we hire from these resumes.