Regulatory Program Director - Devices and Combination Product
Regulatory Program Director - Devices and Combination Product
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1 Vacancy
Job Description
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 Position
We focus on the longterm leading investment in research and development striving to improve lives today and for generations to come.
The Regulatory Program Director is responsible for developing and driving regulatory strategies for combination products and standalone physical devices in accordance with domestic and international regulations and mentorship. In addition to portfoliorelated responsibilities the individual plays a role to build regulatory capabilities craft regulatory policy and establish the vital device regulatory infrastructures/processes to support our portfolio.
At this level the individual (a) has indepth specialist knowledge of own job field and broad knowledge of related subject areas in the field (b) chips in by participating in large/global crossfunctional or crosschapter squads where it may take a leading role (c) may mentor colleagues and help others develop expertise/skills and (d) navigates in sophisticated situations by applying a diverse skills.
The Opportunity:
Serve as the Device Regulatory Lead role on assigned product teams (prelaunch and postlaunch):
Own the development and implementation of global regulatory strategies for devices including groundbreaking innovative regulatory strategies to advance our pipeline and portfolio. Provide regulatory pathway requirements mentorship and advice to project teams.
Lead and/or support device related health authorities interactions in collaboration with internal team members.
Lead the preparation and submission of relevant device regulatory packages (e.g. briefing packages presubmission IND/CTA BLA/NDA/MAA CEmark 510(k) de novo Notified Body Opinion etc. including responses to questions from health authorities. Responsible for ensuring high quality and timely compilation of contents for the submissions.
Identify and manage potential regulatory risks associated with regulatory submissions. Ensure appropriate communication resolution and/or escalation (as needed) of regulatory risks.
Serve as a device regulatory subject matter expert internally and externally to Roche. Provide regular training internally to enhance organizational knowledge and capability. Coach and mentor junior regulatory affairs professionals.
Lead or represent Pharma Technical Regulatory (PTR) in devicespecific internal initiatives to establish internal regulatory processes and systems. Stay abreast of changing regulatory requirements. Analyze regulations rules or guidance documents and communicate potential impact to internal stakeholders.
Engage with relevant regulatory bodies and industry groups to influence device regulatory standards and regulations that matter to Roches product portfolio.
Build strong collaborations and relationships with internal stakeholders to ensure successful of regulatory submissions.
WHO YOU ARE:
You have a scientific degree an advanced degree desired with a minimum of 10 years of industry experience in regulatory and/or quality related field in the medical device and/or biopharmaceutical industry including applicable experience with devices.
Knowledge of ICH guidance documents and health authority regulations/standards relevant to devices specifically 21 CFR part 4 21 CFR part 820 21 CFR part 803 IEC 62633 ISO 13485 IEC 62304 cybersecurity mobile medical applications digital therapeutic clinical decision support systems and EU Medical Device Regulation.
Experience in leading and securing CEmark 510(k) PMA NDA BLA IND CTA regulatory approvals are highly desirable.
Dynamic personality ability to think outside the box and take smart risks.
Ability to think big picture and focus on details and to collaborate crossfunctionally and divisionally in Roche to leverage regulatory expertise and achieve business needs in a streamline manner.
Effective problem solving and strong organizational skills including ability to prioritize tasks.
Drive for continuous improvements and operate with a lean mindset.
Ability to travel up to 10. Apply now !
Who we are
A healthier future drives us to innovate. Together more than 100000 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 lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10700 employees from over 100 countries come together at our Basel/Kaiseraugst site which is one of Roches largest sites. Read more.
Besides extensive development and training opportunities we offer flexible working options 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as childcare facilities medical services restaurants and cafeterias as well as various employee events.
Roche is an Equal Opportunity Employer.
Required Experience:
Director
Employment Type
Full-Time
