Sr. Director, Regulatory Process And Compliance

The Role:

The Sr. Director of Regulatory Process and Complianceposition will work cross-functionally to drive activities that will ensure a state of continuous compliance at Moderna and build inspection-preparedness capabilities and sustain a positive compliance reputation between Modernas business partners, Health Authorities and cross-functionally within Moderna. This role will build mechanisms within the business to educate employees on compliance awareness and ensure all levels of regulatory compliance.

The Sr. Director of Regulatory Process and Compliance will provide hands-on support during regulatory inspections and internal audits, and work to ensure that all identified content is organized, current and readily accessible. Due to the nature of the products that Moderna manufactures and markets, significant attention to and experience with quality systems as it applies to biologic and/or immunotherapy products is critical.

Here's What Youll Do:

• Apply strong critical thinking skills to serve as a regulatory thought partner to the various GxP (GMP, GCP, PVP and GLP) functions and inspections leadership teams regarding emerging compliance issues and topics.

• Lead proactive evaluation and education of local and global compliance on current and emerging regulatory trends within biologics and/or combination products.

• Define and implement systems and metrics for measuring and maintaining regulatory compliance across Global regulatory Sciences (GRS) operations (e.g. Commitments).

• Manage the GRS CAPA framework, including providing CAPA support and follow ups.

• Custodian of GRS processes and procedure, ensuring alignment and Compliance, in close collaboration with R&D Quality Assurance

• Manage GRS training curricula and LMS training metrics in close collaboration with GRS line managers.

• Play a key role in defining and developing new digital product testing strategies and ongoing method development.

• Perform evaluations of GxP compliance across all areas of the site as well as evaluating policies, procedures and processes.

• Collaborate to provide solutions and direction to other R&D and Supply Chain departments on quality and regulatory issues.

• Partner with GRS functional areas to benchmark leading practices and recommend improvements to ensure that Moderna is inspection ready.

• Identify trends in recent regulatory inspections and translate these into recommendations to improve inspection preparedness.

• Direct communications, verbal or written, with the Health Authorities as required.

• Is a leader both in GRS and within R&D, contributing to cross-functional initiatives and influencing the field as applicable.

• Provides leadership and development, including those that serve as global regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.

Heres What Youll Bring to the Table:

• To be considered for this role you must hold at least a Bachelor of Science (BS) degree in chemical engineering/chemistry/life sciences and 10+ years in the pharmaceutical or biotechnology industries or preferably a Master of Science (MS) degree in one of the core Sciences

• Demonstrated knowledge in industry practices and regulations across multiple health authorities

Knowledge, Skills & Abilities

• Ability to adapt to working effectively within a variety of situations

• Ability to help drive an active and compliant quality culture

• Adapt enthusiastically to organizational change and changes in job demands

• Ability to effectively express ideas in written and oral context; to work co-operatively with others; genuine desire to be a part of a team and contribute to organizational and team goals.

• Embed discipline and thoroughness in approaches to problem solving

• Pursue tasks with energy, drive and initiative, even in the face of adversity; comfortable in a results-driven, highly accountable environment where you can make an impact

• Build productive working relationships across a diverse spectrum of people

• Ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards under pressure

• Lead complex or highly complex or multiple projects. Lead functional GRS teams and represents GRS at project team meetings. Define strategies and provide tactical guidance to collaborate cross-functionally

• Promote global regulatory compliance and/or oversees staff responsible for its implementation

• Ensure project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner

• Proactively anticipate compliance risks and take responsibility for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.

• Provide advise on Health Authority submission compliance (labeling updates, annual reports, post approval commitments, etc.)

• Oversee and provide advice in vendor compliance for regulatory activities and submissions as necessary

• Participate in, lead and influence departmental and cross-functional task-forces and initiatives

• Lead regulatory compliance reviewer in due diligence for licensing opportunities

• Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  Vacation, sick time and holidays
  Volunteer time to participate within your community
  Discretionary year-end shutdown
  Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, theinfrastructure 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 peopleare 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.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

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 an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. Were focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to 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 make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com. (EEO/AAP Employer)

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