Location: South San Francisco, CA
Associate Regulatory Program Director- Small Molecule Products, CMC
The Associate Regulatory Program Director position within the Technical Regulatory (PTR) organization will be responsible for developing post market regulatory strategies and initiatives for small molecule products. The position requires an extensive technical regulatory (CMC) knowledge and demonstrated ability to propose sound regulatory strategies for post approval submissions and requirements of US FDA and global regulatory requirements as needed.
The individual will work with a global cross-functional project teams to develop post market regulatory strategies and ensure the success of regulatory submissions and approvals.
Primary Responsibilities include:
• Lead the development and implementation of predominantly US specific but also global post marketing regulatory strategies for small molecule products.
• Author and/or review annual reports, supplemental submissions and maintenance of product approvals and registration.
• Manage the preparation and submission of briefing packages and CMC sections of NDA and MAA (as needed), including responses to questions from health authorities. Responsible for timely compilation of all necessary CMC documents to support technical contents of regulatory submissions.
• Review change controls, determine the level of change, regulatory impact and consequent submission requirements from the perspectives of US and global regulatory landscape (as needed).
• Build strong collaborations and relationships with internal stakeholders to ensure successful execution of regulatory submissions and approvals.
• Proactively provide strategic input and technical guidance to development teams as it pertains to post approval regulatory requirements.
• Strategize with and advise internal stakeholders and effect aligned regulatory strategies.
• Communicate and negotiate with internal regulatory advisory committees, regulatory authorities and other internal and external stakeholders.
• Lead and/or participate in Technical Regulatory Teams.
• Serve as a small molecule product regulatory subject matter expert in Roche/Genentech.
• Provide training for stakeholders on current and new regulatory requirements to ensure company-wide compliance.
• Represent PTR in internal/external small molecule product specific initiatives and working groups.
• Ensure the department’s deliverables and objectives are met.
• Generate timely, complete and accurate updates of product status, changes to regulatory strategies, timelines and risks. Responsible for ensuring management, team members and stakeholders are kept current.
• Stay abreast of evolving regulatory requirements relevant to small molecule products. Analyze new regulatory requirements, regulations, rules, or recommendations and advise potential impact to internal stakeholders.
• Must have a scientific degree, an advanced degree desired.
• 7 plus years of industry experience in regulatory, manufacturing, or quality related field in the small molecule product and/or biopharmaceutical industry with extensive hands on technical regulatory (CMC) knowledge.
• Expertise in US regulatory environment complemented by general knowledge of global regulatory landscape to achieve strategic goals.
• Expertise in developing positions on regulatory risk-benefit.
• Experience in a multinational/multicultural working environment.
• Knowledge of ICH guidance documents and FDA regulations/standards relevant to small molecule products, especially in post marketing.
• Excellent communication, collaboration, and interpersonal skills.
• Effective problem solving and strong organizational skills, including ability to prioritize tasks.
• Ability to quickly learn and adapt globally deployed set of regulatory tools and processes
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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