Regulatory Affairs Manager

Roche

1d•$106,000 - $197,000•Onsite

About The Position

At Roche Global Regulatory Affairs, we strive to be the world's best Regulatory organization, championing patient access to the world's best diagnostics. Our team is tasked with regulatory projects as well as overarching regulatory topics with specific focus in systems and software including hardware-software instrument systems. This role will specifically support our Sequencing portfolio in our Molecular Customer Area. You can expect an open-minded work environment, where you will be working closely with colleagues in other departments and other counties.

Requirements

Bachelor’s / Master degree in Life Science, Data Science or related subject or equivalent experience. Advanced degree preferred.
3-5 years experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs/Medical devices/Pharma/Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.
Knowledge of the European, US, China and other international regulations and demonstrated ability to adequately interpret and implement quality standards considered an advantage.
Demonstrated the ability to manage more complex work and/or at parts of global projects.
Knowledge of USFDA regulations including Research Use Only (RUO) and IVD marketing pathways.

Nice To Haves

Experience with complex regulatory product launch strategies including advertisement and promotional reviews for Research Use Only (RUO) and IVD products pertaining to Sequencing technologies.

Responsibilities

Oversee regulatory document and submission compilation, including the development of submission/product registration dossiers of more complex products/programs.
Develop and manage parts of comprehensive global regulatory submissions and registration plans.
Interface with external management.
Understand the structure, key roles and responsibilities of external customers/stakeholders and communicate timely and effectively the needs of external customers/stakeholders.
Build effective and enduring external relationships and apply effective stakeholder management practices.
Contribute to audits by supporting preparation, execution and follow up.
Lead the organization to adapt to the evolving regulatory environment and requirements.
Have an understanding of external environmental changes, precedents, to navigate complex situations and influence strategies and decision making.
Interpret and apply understanding of the regulators' thinking to projects and apply strategies to the different needs of different regions without significant guidance.
Proactively create unique/innovative regulatory strategies and influencing approaches to avoid regulatory obstacles and accelerate world wide approvals.
Effectively partner with and influence stakeholders to understand and provide best solutions.
Take initiative to address problems or opportunities and involve collaborators for best solutions.
Develop relationships that significantly influence the current and future direction for Roche and our products.
Make decisions even outside of scope/comfort zone and proactively initiate activities independently.
Embrace good decision making principles.
Model VAAC Leadership and agility.
Identify opportunities to develop VACC competency.
Act with integrity, courage, passion and honor commitments and contribute to an inclusive environment which supports all dimensions of diversity.
Pull people together around a common goal and seek to understand and build on different perspectives to enhance outcomes.
Address and resolve conflict by creating an atmosphere of openness and trust.
Bring out the best in people and teams.