Sr. Director of Regulatory Compliance

**The Role**:
The Sr. Director of Regulatory Process and Compliance position 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 Moderna’s 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 You’ll Do**:
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.

**Here’s What You’ll 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-func