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About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Competitive salary package
- Broad range of benefits
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsdrug development processregulatory documentsorphan drugsglobal regulatory strategiesFDAEMAPMDAregulatory legislationhealth care business practices
Soft Skills
mentoringcoachingrelationship buildingorganizational skillsproject managementpresentation skillswritten communicationverbal communicationleadershipteam development
Certifications
PhDPharmD