SubChapter Lead Regulatory Affairs - Lab Coagulation and Clinical Chemistry

About the role

As a Lab Coagulation and Clinical Chemistry II Subchapter lead in the Medical Value Assays Chapter, you will be a member of the Medical Value Assays Regulatory Affairs Leadership Team (MVA RALT). In this position, you will be a leading figure and key point of contact for Roche Diagnostics’ regulatory capabilities in Lab Coagulation and Clinical Chemistry. You will improve the subchapter’s overarching expertise based on current and upcoming needs to deliver on network priorities (e.g., upcoming portfolio investments with new technology skills needed).

Responsibilities

• Develop and coach 10-15 Regulatory Affairs staff to enable the greatest impact for our customers.
• Nurture and develop an empowered, knowledgeable, effective, and efficient group of subject matter experts (SMEs) within the subchapter with the capabilities to support Roche Diagnostics’ efforts with best-in-class expertise.
• Act as subject matter expert with the US FDA, Notified Bodies, international regulatory agencies, and other regulatory bodies to advance project objectives.
• Monitor the global regulatory environments and provide staff and stakeholders with assessments of the impact of new and changing regulations.
• Responsible for effective resource management across the team, in alignment with the respective Lifecycle teams.
• Drive process standardization and reuse where it makes sense (common assets, technical standards) while balancing creativity and innovation.
• Enable the organization’s New Ways of Working by acting as a role model for Agile Leadership behaviors, as well as for our culture and mindset as defined in We@RocheDiagnostics.
• Commit to cross-functional collaboration and breaking down silos to achieve the best results for the organization.
• Navigate within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication, and consensus-building skills.

Requirements

• Bachelor or advanced degree in science or a related field.
• General understanding of the Diagnostics industry, lifecycle & development process, and global trends.
• 7+ years of experience in Regulatory Affairs within the diagnostics industry or a related field with knowledge of IVD, Pharmaceutical, and/or Medical Device industry; Regulatory Compliance, Federal cGMP’s and QSR’s, ISO13485, and 27001.
• Experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China, preferred).
• Strong track record of building and nurturing capabilities such as technical regulatory knowledge, strategic thinking, verbal and written communication, and stakeholder management.
• History of successful interactions with regulatory bodies.

Leadership and People Development

• Ability to lead with a creative attitude, high self-awareness, and act as a coach and mentor to other leaders and partners.
• Demonstrated ability to build networks and inspire agile work practices.
• Empathy towards the needs of Squads and other Chapters combined with the skill of prioritizing resource involvement.
• Demonstrated success in establishing a high-performing environment with an excellent reputation, attracting the best talent, developing, and inspiring them.
• Ability to define career progression and development capabilities for Regulatory Affairs in networked organizations.

Locations

You can be based in Indianapolis, Penzberg, Mannheim, Rotkreuz, Motherwell, Branchburg, Tucson, Pleasanton, Santa Clara, or Carlsbad. Relocation benefits are not available for this position. As this is a global role, international business travel will be required depending on the business location of the successful candidate and ongoing business project activities.

Pay

The expected salary range for this position based on the primary location of Indiana is $111,200 to $258,700. 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.

Benefits

This position qualifies for the benefits detailed at the provided link for the primary posting location (Indianapolis). If you are interested in additional locations where the role may be available, relevant compensation details will be provided later in the hiring process.