South San Francisco
California, United States of America
The Regulatory Program Manager/Associate Regulatory Program Director position within the Technical Regulatory (PTR) organization will be responsible for developing and executing regulatory strategies and initiatives for combination products.
• Lead or support the development and implementation of global regulatory strategies for combination products and devices.
• Manage the preparation and submission of briefing packages and CMC sections of
IND/IMPD and BLA/NDA/MAA, including responses to questions from health authorities. Responsible for timely compilation of all necessary CMC documents to support technical contents of regulatory submissions.
• Serve as a combination product and device regulatory subject matter expert in
Roche/Genentech. Provide regular training internally to enhance organizational knowledge
and capability related to combination products and devices.
• Build strong collaborations and relationships with internal stakeholders to ensure successful
execution of regulatory submissions.
• Stay abreast of changing regulatory requirements relevant to combination products/devices. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders.
• Must have a scientific degree, an advanced degree desired.
• A minimum of 5 years of industry experience in regulatory, manufacturing, or quality related
field in the medical device and/or biopharmaceutical industry, including applicable experience with combination products or medical devices.
• Knowledge of ICH guidance documents and health authority regulations/standards relevant to
combination products or medical devices, specifically 21 CFR part 4, 21 CFR part 820, 21 CFR part 803, IEC 62633, ISO 13485, and EU Medical Device Regulation.
• Knowledge of software regulatory requirements and technical standards (IEC 62304).
• Regulatory experience of emergency use products is desirable.
• Excellent communication, collaboration, and interpersonal skills.
• Dynamic personality, ability to think outside the box and take smart risk.
• Ability to think “big picture” and focus on details.
• Effective problem solving and strong organizational skills, including ability to prioritize tasks.
• Drive for continuous improvements and operate with lean mindset.
10% international and domestic travel necessary.
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
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