Regulatory Affairs Manager
About the role
The Position A healthier future. It’s what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That’s what makes us Roche. 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 Companion Diagnostics.
Responsibilities
- Oversight of regulatory document and submission compilation, including the development of submission/product registration dossiers of more complex products/programs.
- Development and management of 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.
- Have the ability to 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 worldwide approvals.
- Effectively partner with external and internal 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.
- Have courage to 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.
- Address and resolve conflict by creating an atmosphere of openness and trust.
- Bring out the best in people and teams.
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.
Preferred Qualifications
- Experience in Companion Diagnostics.
- Experience with systems and software.
Locations
You are local to Tucson, Indianapolis or Branchburg. No relocation benefits are available for this position.
Pay
The expected salary range for this position based on the primary location of Arizona is $106,100 and $197,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.
Benefits
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.