argenx
United in our commitment to improve the lives of patients
Senior Director, Asset Regulatory Affairs Lead
Location
Massachusetts
Posted
27 days ago
Salary
Not specified
Postgraduate Degree15 yrs expEnglish
Job Description
• Provide strategic, operational and tactical regulatory insight on global activities for assigned programs
• Work with the argenx regulatory team to provide strategic regulatory guidance
• Articulate global regulatory strategy to Sr. Management
• Partner across all functions of the asset teams
• Collaborate with asset teams, IDTs, and PMO/Reg PM staff
• Oversee and mentor members of the regulatory community
• Build and maintain relationships with health authorities and external partners
• Represent the company in external forums and regulatory working groups
• Collaborate with the regulatory intelligence team
Job Requirements
- Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations
- at least 5-7 years in global leadership roles
- PhD or PharmD preferred
- experience in the development of therapeutics for autoimmune neurology, renal or rheumatology conditions
- understanding and experience with biologic drugs for orphan and pediatric indications
- ability to coordinate the development of critical regulatory documents with a focus on FDA, EMA, and PMDA
- strong scientific background
- ability to interact with scientists and clinicians
- familiarity with current and emerging regulatory legislation and industry trends
- highly developed organizational and project management skills
Benefits
- retirement savings plans
- health benefits
- short-term and long-term incentive programs
- inclusive environment
