Global Program Regulatory Director – Digital and Medical Device Dev. job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
Novartis has embarked upon a digital transformation to improve the way the company uses data in drug discovery and development, engages with patients, doctors and other stakeholders, as well as automating business processes. The Global Program Regulatory Director (GPRD) will be a global regulatory affairs (RA) leader in development and registration of digital applications, medical devices including software, digital therapeutics and digital/device combinations in the ophthalmology area, and will represent RA on the Global Program Team (GPT). Prior experience in Class 1 and 2 medical device development and regulatory affairs is essential, including experience with IDE, 510(k), PMA applications and CE technical files. Successful demonstration of the ability to work with EU Notified Bodies is also required. He or she is expected to function independently with minimal supervision as a core member of the GPT to define and implement the global regulatory strategy for the development, submission, approval and life cycle management of the project(s). The GPRD is responsible for leading a high-functioning global regulatory subteam and is expected to be adept at managing multiple projects and stakeholders.|
Regulatory Strategy: • Provide regulatory leadership for the development of a variety of digital applications and medical devices in the ophthalmology area. This will include apps, medical devices, and software geared toward optimization of patient diagnosis and/or treatment referral and management; digital therapeutics; and digital stakeholder engagement. • Interface effectively with associated drug/device development teams • Develop high quality and globally aligned regulatory strategies to achieve optimal development objectives and life cycle management plans. • Ensure that regional/country input is sought and incorporated into global regulatory strategy • Collaborate effectively with external development partners • Provide strategic input to GPT and RA team on key Health Authority (HA)/ Notified Bodies regulatory documents including CE Technical files, obtaining appropriate line endorsement as appropriate. • Provide strategic input, review and approve study protocols and protocol amendments • Lead RA activities regarding Novartis safety risk communications for the assigned projects. • Provide strategic regulatory input into Business Development & Licensing (BD&L) due diligence evaluations. Health Authority Interactions: • Develop global regulatory strategy and plans for Health Authority (HA)/Notified Bodies interactions as appropriate. • Contribute to and review HA/Notified Bodies responses, to ensure appropriate, consistent and complete answers to questions. Ensure responses are in line with development strategy. • Lead interaction with HA/Notified Bodies during key meetings • Provide leadership by supporting the Global Program Regulatory Managers (GPRMs) in their direct interactions with HA/Notified Bodies as appropriate. Submissions and Approvals: • Lead the global submission planning process • Lead regulatory submission process throughout the project lifecycle on behalf of GPT. This includes oversight of submission plan, generation and sign-off of key regulatory/response components. • Proactively address issues, gaps, options and trade-offs for the development plan to increase the probability of an optimal and timely submission and approval/clearance. Certifications and Product Information: • Lead CE marking process • Develop intended use statements, and where applicable, the Core Data Sheet (CDS)/Instructions for use (IFU), with input from line function members. • Guide and support GPRMs and CPOs to ensure consistency and compliance with CDS.Science-based BS or MS with requisite experience and demonstrated capability. Advanced degree (MD, PhD, PharmD) preferred. Fluent in English as a business language. Additional language is an asset. Minimum 5 years of experience in medical device (including software)-focused global regulatory affairs. Ophthalmology, digital device, and AI-based algorithm registration experience are a plus. Experience will ideally span early to late development in most or all of the following areas: • Innovation in regulatory strategy. • Prior history with post-marketing/brand optimization strategies and commercial awareness • Leadership role in health authority negotiations in multiple regions. • Proven success in global Class 1 and 2 medical device regulatory submissions and clearance/approvals. • Proven success in collaborating with EU Notified bodies to gain medical device clearance/ approvals. • Regulatory operational expertise. • Minimum 2-5 years of demonstrated leadership and accomplishment in regulatory affairs in a global/matrix environment in the pharmaceutical industry.