Early Development Global Regulatory Lead
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Early Development Global Regulatory Lead at argenx focusing on regulatory strategies and patient-centric development pathways. Overseeing regulatory affairs to support early asset progression in biopharmaceuticals.
Responsibilities:
- Act as a key member of the EDRT establishing and growing the team in alignment with argenx culture
- Co-creation and implementation of innovative global regulatory strategies
- Ensure patient-centricity is embedded in regulatory strategy
- Represent EDRT within key early development governance forums
- Serve as the conduit between EDRT and asset teams to facilitate transition of programs
- Mentor and coach EDRT members
- Build relationships with internal stakeholders
- Monitor, interpret and communicate evolving global regulatory requirements
- Oversee regulatory affairs vendors involved in EDRT activities
Requirements:
- Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations
- At least 5-7 years in global leadership roles with a focus on major regulatory regions such as FDA, EMA, or PMDA
- PhD or PharmD preferred
- Prior experience in rapidly growing pharmaceutical organizations is desirable
- Thorough understanding of the drug development process with expertise in orphan drugs
- Ability to interact with scientists and clinicians
- Demonstrated ability to coordinate the development of regulatory documents
- Experience interacting with regulatory authorities, especially FDA and EMA
- Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally
- Highly developed organizational skills and project management skills
- Outstanding presentation, written and verbal communication skills
- Strong leadership with proven ability to build, motivate and develop a team
Benefits:
- Competitive salary package
- Broad range of benefits
Similar Jobs
Manager, Regulatory Compliance
Regulatory Compliance Manager responsible for overseeing product safety and compliance for Eos Energy's Z3 batteries. Collaborating with engineering, clients, and regulatory bodies to maintain safety standards.
Regulatory Affairs Consultant – Clinical Regulatory Affairs
Regulatory Affairs Consultant guiding clinical studies through regulatory processes for Parexel. Collaborating with cross-functional teams to ensure compliant and efficient trial execution.
GRC Engineer
GRC Engineer at WorkOS managing compliance, risk, and customer trust programs. Leading initiatives for certifications and automating GRC processes in a remote environment.
Specialist, Regulatory & Site Activation
Specialist in Regulatory & Site Activation at Worldwide Clinical Trials in Australia. Responsible for driving regulatory submissions with a focus on quality and compliance.
Head of Compliance
Head of Compliance for beqom, ensuring global compliance and governance while leading a high-impact team. Focused on regulatory frameworks in a dynamic SaaS company.
Compliance Officer
Compliance Officer overseeing projects ensuring adherence to laws and regulations at Codekeeper. Leading compliance initiatives and managing project timelines in a fast-paced, remote-first environment.
Senior Regulatory Policy and Intelligence Manager
Regulatory Manager at Amgen driving alignment on regulatory policies and engaging with external stakeholders. This role requires in-depth knowledge of legislation and strong communication skills.
SAP GRC Consultant – Senior
SAP GRC Senior Consultant at Mollica IT enhancing security and compliance measures through SAP solutions. Collaborating in project implementations and multi-functional governance activities.
IT Specialist, SOX Compliance, SAP GRC
Specialist IT SOX and SAP GRC Compliance ensuring integrity and compliance of key reports. Support for financial and IT control environments while contributing to SOX processes in a biotech company.
Data Governance, Risk and Compliance Lead
Lead Data Governance initiatives at Auto Club Enterprises, ensuring data trust and compliance across the organization. Overseeing implementation of governance frameworks and project timelines.
Manager, Clinical Quality and Compliance
Manager Clinical Quality and Compliance overseeing quality management and regulatory adherence at Dexcom. Collaborating cross-functionally to drive clinical quality initiatives and improve patient safety.
IT Compliance Analyst – IV
IT Compliance Analyst IV at Hanger, Inc. leading audits and implementing compliance frameworks for IT systems and processes.
Associate Director, LIFT Program Compliance
Associate Director overseeing compliance for the Texas Education Agency’s LIFT Program. Leading complex projects to ensure adherence to grant requirements and improve educational outcomes.
Compliance Verification Engineer – Landing Gear
Compliance Verification Engineer at Expleo, focusing on landing gear compliance with airworthiness standards. Collaborating with aviation authorities and design teams to ensure safety and regulatory requirements.
Associate Director, Regulatory Affairs, Marketed Products Portfolio
Associate Director guiding regulatory strategy for GE HealthCare's pharmaceutical diagnostics. Leading submissions and compliance for marketed products in key markets such as US and Canada.
Executive Director – Regulatory Affairs, Combination Products & Devices
Executive Director overseeing global regulatory strategies for combination products and devices at Gilead. Fostering collaboration across functions to ensure regulatory excellence and compliance.
Director, Compliance & Enablement
Director of Quality responsible for ensuring operational excellence and managing quality processes at Jabil. Overseeing recruitment, employee development, and performance management across the quality operations team.
Grants & Compliance Manager
Grants & Compliance Manager overseeing compliance for World Bank-funded project with strong focus on monitoring and documentation in Ethiopia and similar regions.
Compliance MLRO
Compliance & MLRO Officer ensuring regulatory compliance and conducting employee training at INGOT. Responsible for maintaining policies, audits, and reporting to Seychelles authorities.
Health, Safety & Compliance Manager
Health & Safety Manager overseeing compliance and safety across UK fertiliser manufacturers. Leading a team in providing expertise and support to ensure health and safety regulations are met.