Sr. Manager, Regulatory Compliance

vor 3 Wochen

Basel, Schweiz Moderna Therapeutics Vollzeit

**The Role**:
Reporting to the Director Quality Systems & Compliance the Sr. Manager / AD Regulatory Compliance will be responsible to be the liaison function between International Quality and the Regulatory CMC functions of Moderna International. The role will implement and continuously improve required processes to ensure the compliance of Moderna’s product with the registered dossiers.

**Here’s What You’ll Do**:
Review and approve regulatory submissions

Act as a Subject Matter expert for dossier content related questions and provide training and learning to the INTL team on the content and interpretation of the dossiers

Implement, execute, maintain and improve processes for sharing relevant dossier parts amongst the Moderna network and with 3rd parties, as appropriate

Implement, execute, maintain and improve processes for assessing Deviations with potential impact to the registered details

Provide assessments and guidance on regulatory compliance impact assessments of Change Controls, Deviations and other QMS processes

Support quality-related information requests raised by partners/customers and International Health Authorities

Support compliance checks at CMOs and internally

Work collaboratively with the digital team on the GXP integrated digital landscape to support all electronic quality systems, the utilization of data to accelerate and inform process and system performance and value stream roadmaps for long range planning.

Support and/or lead programs strengthening the regulatory compliance of Moderna and support continuous improvement for the rapidly expanding GXP international environment.

**Here’s What You’ll Bring to the Table**:
10 years+ experience in Regulatory Compliance or equivalent functions in GxP-regulated Pharmaceutical Industry

Bachelor’s degree or higher, preferably in Sciences or Engineering

Proficient in English, additional languages are a plus

Proactive Team Player with strong interaction skills who will flourish in a dynamic environment

Ability to manage stakeholders at all levels and achieve in a matrix organization

Proven track record in management of regulatory dossier compliance reviews

Proven track record in solution-oriented handling of complex regulatory impacting Change Controls and Deviations

Moderna offers personalized benefit programs and well-being resources as unique as our global workforce so employees can do their best work.

We recognize and appreciate your diverse needs and interests and do our best to support you at work and at home with:
Quality healthcare and insurance benefits
Lifestyle Spending Accounts to create your own pathway to well-being
Free premium access to fitness, nutrition, and mindfulness classes
Family planning and adoption benefits
Generous paid time off, including vacation, bank holidays, volunteer days, sabbatical, and a discretionary year-end shutdown
Educational resources
Savings and investments
Location-specific perks and extras

The benefits offered may vary depending on the nature of your employment with Moderna and the country where you work.

About Moderna
In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

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

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