Regulatory Innovation & Sustainment Leader
Genentech
The Position As a Regulatory Innovation & Sustainment Leader in the Pharmaceutical Development Regulatory (PDR) Innovation & Sustainment chapter, you will drive the digital transformation of regulatory workflows, specifically focusing on AI and data strategy. You will bridge the gap between business needs and technical execution, fostering a culture of innovation while ensuring operational excellence and compliance. In PDR we develop and maintain our licenses - we influence Health Authorities in their thought process to develop regulations. The Opportunity: Strategic Leadership: Shape strategy and lead high-impact, complex, cross-functional project teams to deliver tangible business outcomes. Domain Expertise: Serve as a recognized subject matter expert in Digital, AI, and Data, leveraging a broad cross-discipline skill set to drive innovation. Team Empowerment: Cultivate a collaborative team culture where members are empowered to influence stakeholders and drive results. Mentorship & Thought Leadership: Act as a go-to thought leader within PDR, coaching and upskilling junior colleagues to build internal capability. Stakeholder Management: Influence cross-functional teams, including Health Authorities, government entities, politicians for key topics related to regulatory science and solution & sustainment. Has established networks and utilizes networks with stakeholders external to Roche. Change Management: Champion a culture of continuous improvement, experimentation, and VACC (Visionary, Architect, Coach, Catalyst) leadership principles. Capability Building: Mentor colleagues, build talent, and manage complex, high-impact projects that unlock enterprise-wide benefits. Who You Are: Deep knowledge of process redesign for AI, data management practices with overarching business strategy to drive innovation. Proven relevant work experience which includes supporting cross-functional teams in a scientific environment . Proven ability to apply system thinking and an enterprise-wide mindset to lead change within a matrixed organisation. Maintain a strong commitment to medical compliance, integrity, and the Roche Group Code of Conduct. Expert-level ownership of complex, high-impact deliverables. Operates with distributed authority and accountability. Makes pragmatic, fit-for-purpose decisions, defaults to working transparently, and actively seeks advice to iterate and experiment. Employs a continuous learning mindset and actively acts on feedback. Fosters community by prioritizing personal growth, teamwork, and self autonomy Measurable reach and strategic results across the organization. Drives outcome-oriented results through strategic agility. Build, share, and leverage interconnected networks to exchange knowledge and advance key insights. Demonstrated ability to influence and negotiate with global stakeholders and external entities by communicating transparently, listening actively and building mutual trust. Collaborates through iterative feedback while recognizing and elevating peer contributions. Technical depth, practical expertise, and leadership maturity. Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants. #J-18808-Ljbffr Genentech
- ...access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position As a Regulatory Innovation & Sustainment Leader in the Pharmaceutical Development Regulatory (PDR) Innovation & Sustainment chapter, you will drive the digital...RegulatoryContract workWork experience placementFlexible hours
- Roche in Welwyn is seeking a Regulatory Innovation & Sustainment Leader to drive the digital transformation of regulatory workflows, with a focus on AI and data strategy. You will bridge business needs and technical execution while upholding compliance and operational...Regulatory
$26.1 - $43.07 per hour
...profitability, expense control, buying, merchandising, labor, regulatory compliance and special projects as assigned. Accountable... ...and productive working relationships with department leaders and with vendors. Sustains exceptional level of knowledge / awareness of relevant...RegulatoryHourly payFull timePart timeSeasonal workWork at officeFlexible hoursNight shift- Genentech seeks an executive leader to architect and drive the long-term CDx and clinical platform strategy for Translational... ...external teams to advance diagnostic co-development, regulatory alignment, and biomarker innovation across the Roche/Genentech ecosystem. You will lead a...RegulatoryRelocation package
$131.2k - $174.98k
...their lives. Since our founding in 2010, innovation has been our winning differentiation,... .... We want our legacy to be the leaders we produce for the industry. Will you be... ...orchestration design complies with the regulatory, legal, and privacy requirements governing...RegulatoryHourly pay- Genentech in South San Francisco, CA is seeking a Regulatory Innovation & Sustainment Leader to drive the digital transformation of regulatory workflows, focusing on AI and data strategy across PDR. You will bridge business needs with technical execution to enable innovation...Regulatory
$196k - $245.2k
...Acadia is committed to turning scientific promise into meaningful innovation that makes the difference for underserved neurological and... ...across Business Development, Clinical and Nonclinical Development, Regulatory, CMC, Commercial, Finance, Legal, and other functions, the...RegulatoryWork at officeLocal areaRemote workNight shift3 days per week$261k - $304.5k
...company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new... ...clinical research, clinical supply chain, CMC, quality, regulatory, program & portfolio management.This role will include direct...Regulatory$22.55 - $36.08 per hour
...the grocery industry. Assists the Team Leader in all aspects of daily operations including... ...control, buying, merchandising, labor, regulatory compliance and special projects as... ...counsels Team Members in a manner that sustains a high-performance team and minimizes turnover...RegulatoryHourly payFull timePart timeSeasonal workWork at officeFlexible hoursNight shift$22.55 - $36.08 per hour
...the grocery industry. Assists the Team Leader in all aspects of daily operations... ...control, buying, merchandising, labor, regulatory compliance and special projects as assigned... ...counsels Team Members in a manner that sustains a high-performance team and minimizes turnover...RegulatoryHourly payFull timePart timeSeasonal workWork at officeFlexible hoursNight shift- ...California is seeking an Associate Director, Medical Writing to lead and oversee the creation and review of high-quality clinical and regulatory documents in compliance with ICH and global guidelines. The role emphasizes project leadership, cross-functional collaboration...Regulatory
- ...commercialization. Based in South San Francisco with up to two remote days weekly, this leader will mature QMS, drive inspection readiness, and partner with Manufacturing, Regulatory, and Clinical QA to ensure patient safety and regulatory readiness. #J-18808-Ljbffr...RegulatoryRemote work
- ...Biological Safety Manager to lead the Biosafety Program and IBC oversight in South San Francisco, CA. You will drive EHS integration, regulatory compliance, and continuous improvement across laboratory and workplace environments. Responsibilities include directing biosafety...Regulatory
- ...trials for its cutting-edge LYTAC therapeutics. You will shape development trajectories, collaborate across clinical operations, regulatory affairs, and biostatistics, and contribute to pivotal regulatory submissions. The role emphasizes leadership in study design, safety...Regulatory
- ...collaborate with local EHS and site leadership to implement policies that promote a safe, compliant work environment. The role covers regulatory inspections, incident investigations, risk assessments, and the development of training content. A strong background in...RegulatoryFor contractorsLocal area
- Enigma Search is looking for a Director of Regulatory Affairs to spearhead regulatory strategies in South San Francisco. The ideal candidate will possess a Master’s degree in a life science discipline, with a preference for a PhD, along with at least 10 years in regulatory...Regulatory
- ...Inc. in South San Francisco, CA seeks a Medical Director, Laboratory and Pathology to oversee the lab's operations, quality, and regulatory compliance. This on-site role carries a Tuesday-Saturday schedule and requires strong leadership across pathology and laboratory...Regulatory
- Scorpion Therapeutics is seeking an experienced medical safety leader to oversee pharmacovigilance across the portfolio. You will review... ...medical guidance for case processing teams within global regulatory frameworks. The role requires MD or equivalent, 8-12+ years in...Regulatory
$26.1 - $43.07 per hour
...Prepared Foods Team Leader Provides overall leadership to the Prepared Foods team.... ...control, buying, merchandising, labor, regulatory compliance and special projects as assigned... ...department leaders and with vendors. Sustains exceptional level of knowledge / awareness...RegulatoryHourly payFull timePart timeSeasonal workWork at officeFlexible hoursNight shift- ...efforts. This role involves designing and implementing comprehensive training for rare product launches, ensuring compliance with regulatory standards. The ideal candidate will have at least 7 years of commercial experience in biotech, along with strong leadership and...Regulatory
$190k - $240k
...career with intention. Our culture values professional autonomy, innovation, and meaningful collaboration across offices. We are proud to... .... Support project teams in navigating complex technical, regulatory, and stakeholder challenges. Drive consistency in project delivery...RegulatoryContract workWork at officeLocal areaFlexible hours- Nurix Therapeutics seeks a brilliant, organized leader to provide strategic and tactical medical leadership for global development programs, ensuring safety and regulatory compliance from early research through approval and launch. This executive will lead program teams...Regulatory
$150k - $250k
Ohalo is seeking a Global Crop Product Manager to coordinate go-to-market execution across Breeding, Sales, Channel Management, Regulatory, and Supply Chain from our South San Francisco, CA location. You will own the commercial variety portfolio, lead cross-functional...Regulatory- ...ophthalmology. You will shape strategy from IND/CTA through clinical proof-of-concept and collaborate with Preclinical, Clinical, Regulatory, and computational teams. Reporting to the Chief Medical Officer, this role can be onsite three days per week or hybrid, with...Regulatory3 days per week
$2,000 per month
...financial services space, the biggest bottleneck to their growth and innovation is often the underlying banks and infrastructure stack they... ...strong pulse on market dynamics, competitive positioning, and regulatory developments affecting Column's target customers. Pipeline...RegulatoryWork at officeRemote workFlexible hours- ...NetSuite) and ensure cGMP compliance, with a strong emphasis on inventory optimization, data-driven decision-making, and cross-functional collaboration with Clinical, Commercial, Development, Finance, Manufacturing, Quality, and Regulatory teams. #J-18808-Ljbffr BioSpaceRegulatory
$26.1 - $43.07 per hour
...profitability, expense control, buying, merchandising, labor, regulatory compliance and special projects as assigned. Accountable... ...and productive working relationships with department leaders and with vendors. Sustains exceptional level of knowledge / awareness of relevant...RegulatoryHourly payFull timePart timeSeasonal workWork at officeFlexible hoursNight shift- ...signal detection for its oncology portfolio. The role requires deep pharmacovigilance expertise, leadership experience, and global regulatory knowledge to guide safety decisions across trials and post-marketing activities. The successful candidate will oversee ICSR...Regulatory
- ...oncology and immunology, driving scientific leadership, evidence generation, and cross-functional collaboration to maximize product value. The candidate will partner with Regulatory, Commercial, and Market Access, build a high-performing team, #J-18808-Ljbffr Zai Lab, Ltd.Regulatory
$25.1 - $42.5 per hour
...profitability, expense control, buying, merchandising, labor, regulatory compliance and special projects as assigned. Accountable for Team... ...maintains positive and productive vendor relationships. Sustains exceptional level of knowledge and awareness of relevant...RegulatoryHourly payFull timePart timeSeasonal workWork at officeFlexible hoursNight shift
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