Lead Manager, CMC Regulatory Affairs

2 weeks ago

Foster City, California, United States Gilead Sciences Full time
Position Overview:
As a Lead Manager in CMC Regulatory Affairs at Gilead Sciences, you will play a pivotal role in steering the strategic direction and operational execution of regulatory initiatives within the Chemistry, Manufacturing, and Controls (CMC) domain.

Key Responsibilities:
1. Oversee the preparation and submission of intricate regulatory CMC documents for both investigational and commercial products, ensuring compliance with ICH guidelines and regional regulations.
2. Collaborate effectively with cross-functional teams to formulate a comprehensive CMC submission strategy aligned with organizational objectives.
3. Engage with internal departments and external partners to devise and implement robust regulatory strategies for CMC.
4. Provide expert regulatory guidance, making informed decisions on complex regulatory matters.
5. Assess change proposals for their global regulatory implications and plan necessary amendments.
6. Facilitate the development of CMC regulatory strategies in coordination with development teams and affiliates.
7. Stay abreast of evolving CMC regulatory intelligence, guidelines, and trends to drive strategic policy implementation.
8. Lead interactions with regulatory authorities, managing CMC-related deliverables and commitments.
9. Ensure that project teams and stakeholders are informed of developments that may affect regulatory outcomes, exercising sound judgment in communication.
10. Initiate and contribute to process enhancements that significantly impact the Regulatory Affairs CMC Department.
11. Mentor and coach junior regulatory staff to foster their professional growth.

Qualifications:
- A minimum of 8 years of experience in CMC Regulatory Affairs or related fields, complemented by an advanced degree.
- Proven experience in Life Cycle Management.
- A collaborative, proactive, and highly organized work ethic.
- Demonstrated success in strategic planning and problem-solving within a global matrix environment.
- In-depth knowledge of global regulatory requirements and guidelines.
- Exceptional communication and interpersonal skills.

Preferred Qualifications:
- Background in a scientific or technical field.

Gilead Core Values:
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)

At Gilead, we are committed to fostering a diverse workforce and providing an inclusive environment for all employees.

  • Head of CMC Regulatory Affairs- Small Molecule

    2 months ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Head of CMC Regulatory Affairs- Small MoleculeUnited States – RemoteGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with...

  • Regulatory Affairs CMC Information Systems Coordinator

    2 weeks ago

    Foster City, California, United States TekWissen ® Full time

    Position: Regulatory Affairs CMC – Data Management SpecialistOverview:TekWissen Group is a prominent workforce management provider, collaborating with various industries across the globe. We are currently seeking a dedicated professional to join our client's team, a leading biotechnology firm focused on the research, development, and commercialization of...

  • Senior Director, CMC Regulatory Affairs Biologics Project Lead

    3 months ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Senior Director, CMC Regulatory Affairs Biologics Project LeadUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of...

  • Regulatory Affairs Specialist

    2 weeks ago

    Foster City, California, United States LeadStack Inc. Full time

    Company Overview:LeadStack Inc. is a highly regarded staffing services provider, recognized as one of the fastest-growing certified minority-owned businesses in the nation. We pride ourselves on being a certified Great Place to Work and collaborating with esteemed Fortune 500 companies.Position:Regulatory Affairs Associate IILocation:Foster City, CAContract...

  • Regulatory Affairs Director

    1 day ago

    Redwood City, California, United States Adverum Biotechnologies Full time

    About the RoleWe are seeking a highly experienced and skilled Regulatory Affairs Director to lead our CMC Regulatory strategy for Adverum's gene therapy program/s. As a key member of our team, you will be responsible for developing, executing, and advising on global Regulatory CMC strategies through all phases of our development program/s.Key...

  • Regulatory Compliance Associate

    2 weeks ago

    Foster City, California, United States R&D Partners Full time

    Join a leading biotechnology firm as a Regulatory Compliance Associate focused on CMC (Chemistry, Manufacturing, and Controls) to enhance our Data Administration efforts.Key ResponsibilitiesConduct data entry utilizing internal systems to accurately input and maintain essential product details for various stakeholders.Collaborate effectively with the...

  • Quality Assurance Regulatory Specialist

    2 weeks ago

    Foster City, California, United States R&D Partners Full time

    A leading biotechnology organization is seeking a Regulatory Affairs Specialist (CMC) to enhance the Data Administration team. This position offers a hybrid work arrangement.Key ResponsibilitiesConduct data entry utilizing internal systems to accurately input and maintain essential product details for cross-departmental collaboration.Collaborate effectively...

  • Regulatory Affairs Director

    1 day ago

    Redwood City, California, United States HealthCare Recruiters International Full time

    **About the Role**HealthCare Recruiters International is seeking a highly qualified Director of Regulatory Affairs to join our team. As a key member of our R&D team, you will play a critical role in the development and commercialization of innovative robotic systems for the diagnosis and treatment of patients with advanced surgical interventions.**Key...

  • Head of Regulatory Affairs for Advertising

    1 week ago

    Foster City, California, United States Milestone Technologies, Inc. Full time

    Position OverviewThe Senior Director of Regulatory Affairs for Advertising & Promotion will lead, guide, and provide strategic direction on all advertising and promotional initiatives, ensuring adherence to regulations, alignment with approved product registrations, and compliance with company policies throughout the product lifecycle. This role will...

  • Director, Regulatory Affairs

    1 month ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Director, Regulatory Affairs - InflammationUnited States - California - Foster CityUnited States - New Jersey - ParsippanyGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to...

  • Associate Director, Regulatory Affairs

    1 month ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Associate Director, Regulatory Affairs - InflammationUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients...

  • Regulatory Affairs Manager, International

    1 week ago

    Redwood City, California, United States Pulmonx Full time

    Company OverviewPulmonx is a leading innovator in Interventional Pulmonology, Planning Tools, and Treatments for Obstructive Lung Disease. Based in the United States and Switzerland, Pulmonx is the manufacturer of the Zephyr Valve. The Zephyr Valve was granted breakthrough status and approved by the FDA in 2018, as it represents a breakthrough technology...

  • Associate Director, Analytical Regulatory Sciences, Systems

    3 months ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Associate Director, Analytical Regulatory Sciences, Systems & Operations in CMC Regulatory AffairsUnited States - California - Foster CityGilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug...

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative tools and therapies for Obstructive Lung Disease. Our commitment to excellence is exemplified by our flagship product, the Zephyr Valve, which has been recognized for its groundbreaking technology in the realm of...

  • International Regulatory Affairs Manager

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading innovator in the field of Interventional Pulmonology, specializing in advanced tools and therapies for Obstructive Lung Disease. The company is recognized for its groundbreaking Zephyr Valve, which received breakthrough designation from the FDA due to its significant clinical advantages in lung...

  • Lead Regulatory Affairs Specialist

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a global leader in interventional pulmonology, specializing in innovative tools and treatments for obstructive lung disease. With operations in multiple countries, Pulmonx is renowned for developing the Zephyr Valve, a device that has received breakthrough designation from the FDA due to its significant advantages in non-surgical...

  • Lead Regulatory Affairs Expert

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Company OverviewPulmonx is a leading organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. With operations in multiple locations, Pulmonx is renowned for developing the Zephyr Valve, a groundbreaking device that received FDA breakthrough designation in June 2018. This technology...

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a recognized leader in the field of Interventional Pulmonology, specializing in innovative planning tools and treatments for obstructive lung diseases. With operations in multiple global locations, Pulmonx is renowned for its Zephyr Valve, a device that received breakthrough designation from the FDA in...

  • International Regulatory Affairs Manager

    1 week ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading organization in the field of Interventional Pulmonology, offering innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a groundbreaking device that received breakthrough designation from the FDA in June 2018, as it...

  • International Regulatory Affairs Manager

    2 weeks ago

    Redwood City, California, United States Pulmonx Corporation Full time

    Manager, Regulatory Affairs, InternationalPulmonx is a leading entity in the field of Interventional Pulmonology, specializing in innovative solutions and therapies for Obstructive Lung Disease. The company is recognized for its development of the Zephyr Valve, a device that has achieved breakthrough status and received FDA approval due to its significant...