Regulatory Compliance Manager

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Opportunity

The Regulatory Compliance Manager will partner with stakeholders in the US Diagnostics Affiliate (RDC) to deliver quality and regulatory solutions that enable the business to meet customer/patient needs and US safety, quality and regulatory requirements. The Regulatory Compliance Manager will support one or more Customer Areas and/or other functions engaged in the promotion and commercialization of Roche Diagnostic's products in the US.

The Regulatory Compliance Manager is a senior level individual contributor role that will collaborate with peers and senior leaders across the US Affiliate and the global organization to solve varied, complex and novel issues. The Regulatory Compliance Manager will typically work with greater discretion and latitude. The role requires broad expert knowledge and experience in quality, regulatory and business areas, and strong strategic, collaboration and communication skills, as well as an agile mindset, to evolve the way we deliver solutions and enable accelerated access for our patients.

The Regulatory Compliance Manager may contribute to global cross-functional or cross-chapter squads, taking a leading role and navigating complex situations within the quality and regulatory compliance landscape.

Who You Are

• Bachelor's degree in related field and 8+ years of related experience OR 12+ years of related experience

• Highest level of knowledge of industry quality and regulatory standards and processes

• High learning agility and proven ability to work autonomously

• Applies risk-based problem solving and appropriate business solutions to effectively mitigate compliance risk

• Experience with cross-functional problem solving and driving change through to successful implementation

• Effective in assessment of compliance risks and the ability to communicate potential business impact

• Excellent influencing skills

• Proven track record and experience in building and cultivating relationships with key partners and stakeholders across organizational levels

• Excellent customer service, negotiation, leadership, and communication skills

• Strong process-orientation with proven effectiveness in identifying, developing and implementing scalable/sustainable processes and other continuous improvements to achieve organizational efficiencies and increase effectiveness

Preferred Requirements:

• Bachelor's degree in life sciences or business

• 10+ years of related experience

• Industry experience with advertising and promotional communications approval process

• Experience managing Corrective and Preventative Action (CAPA) activities

• Experience in legal or regulatory affairs

This position is based in Indianapolis, IN and has an in office requirement of 3 days/wk.

The expected salary range for this position based on the primary location of Indiana is $100,800 - $187,200. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits

Relocation benefits are not available for this job posting.

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.