SubChapter Lead Regulatory Affairs - Endocrinology and Fertility

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As the Endocrinology and Fertility 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 Endocrinology and Fertility. 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).

You develop and coach 10-15 Regulatory Affairs staff to enable the greatest impact for our customers. You 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. You act as subject matter expert with the US FDA, Notified Bodies, international regulatory agencies and other regulatory bodies to advance project objectives.

You monitor the global regulatory environments, and provide staff and stakeholders with assessments of the impact of new and changing regulations. You are responsible for effective resource management across the team, in alignment with the respective Lifecycle teams. You drive process standardization and reuse where it makes sense (common assets, technical standards) balancing creativity and innovation. You enable the organization’s New Ways of Working by acting as Role-model for Agile Leadership behaviors, as well as for our culture, and mindset as defined in We@Roche Diagnostics.

You are committed to cross‑functional collaboration and breaking down silos to achieve the best results for the organization. You navigate within a changing organization, maintaining objectivity, respect for differences of opinion, fairness, open communication and consensus building skills.

You have a Bachelor or Advanced degree in science or a related field. You have a general understanding of the Diagnostics industry, lifecycle & development process and global trends. You have 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, ISO
13485 and 27001. You have experience with global submissions for US FDA (Class 1-3), EU Notified Bodies (Class A-D), and International (including China, preferred). You have a strong track record of building and nurturing capabilities such as technical regulatory knowledge, strategic thinking, verbal and written communication and stakeholder management. You have a history of successful interactions with regulatory bodies.

You have the ability to lead with a creative attitude, very high self-awareness and being a coach and a mentor to other leaders and partners. You demonstrate the ability to build networks and can inspire to work agile. You show empathy towards the needs of Squads and other Chapters combined with skill of prioritizing resource involvement. You have demonstrated success in establishing a high performing environment with an excellent reputation attracting the best talent, developing and inspiring them.

You can define career progression…