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argenx · 1 week ago

Sr. Director Asset Regulatory Affairs Lead

United States

Full-time

Remote

Director/Executive

15+ years exp

argenx is a global immunology company developing antibody-based medicines for patients suffering from severe autoimmune diseases. They are seeking a Senior Director of Asset Regulatory Affairs to support the rapid growth of their pipeline and contribute to the development of product regulatory strategies for different indications.

BiotechnologyClinical TrialsTherapeutics

Responsibilities

Provide strategic, operational and tactical regulatory insight on global activities for assigned programs with focus on innovative ways of addressing barriers to development strategies as well as speeding the availability of our products to patients

Work with the rest of the argenx regulatory team, provide strategic regulatory guidance for assigned compound, help guide the organization on the appropriate filing strategy in primary regions, and coordinate across disciplines to ensure timely filings as applicable

Articulate global regulatory strategy to Sr. Management

Partner across all functions of the asset teams to ensure regulatory input is provided in a timely matter to support business decisions

Ensure coordinated regulatory strategy across the regulatory leads on the indication development teams, the asset team and the broader global regulatory team

Collaborate with asset teams, IDTs and PMO/Reg PM staff to plan the global submission timeline for the asset and project resourcing requirements and to ensure regulatory strategies are aligned with broader organizational strategies

Oversee and mentor the members of the regulatory community

Build and maintain strong relationships with health authorities, external partners, and internal stakeholders to facilitate regulatory approvals

Represent the company in external forums, conferences, or regulatory working groups to stay informed of regulatory updates and share insights

Collaborate with the regulatory intelligence team and organizationally with Regulatory Policy to continuously assess regulatory requirements and changes in global markets to anticipate challenges and mitigate risks

Qualification

Regulatory Affairs ExperienceRegulatory Strategy DevelopmentBiologic Drug DevelopmentPhDPharmDProject Management SkillsStakeholder EngagementLeadership SkillsCommunication SkillsCollaboration Skills

Required

Minimum 15 years of regulatory affairs experience within biopharmaceutical organizations, of which at least 5-7 years must have been in global leadership roles with a focus on driving and implementing sound regulatory strategies leading to successful submissions and launches

A thorough understanding and experience with the development and licensure of biologic drugs for orphan and pediatric indications along with knowledge of and monitoring of the evolving landscape of regulations and guidelines

Demonstrated ability to coordinate the development of critical regulatory documents involved in the development and approval of medicines with a focus on FDA, EMA, and PMDA

A strong scientific background and ability to interact with scientists and clinicians

Ability to speak and interact with a diverse group of individuals on technical and business topics

Familiarity with current and emerging regulatory legislation, industry trends, and health care business practices globally

Highly developed organizational skills and project management skills with demonstrated strengths in strategic planning, delegation, resource allocation, and workload prioritization

Create a culture of collaboration, excellence and innovation which inspires team members to be trailblazers and perform at their highest abilities, optimizing their effectiveness to enable the timely and quality creation of local submissions

A clear communicator who can influence stakeholders effectively, both internally and externally, with outstanding presentation, written and verbal communication skills

Track record of successful interactions with regulatory and health authorities

You are a connector, building relationships and partnering across the organization to achieve the company goals

You excel in a fast-paced, results-driven, highly accountable environment

You are pragmatic, yet creative and innovative and lead while 'rolling up your sleeves' to get it done

You show strong leadership with proven ability to build, motivate and develop a team

You resonate with the values of argenx and you are ready to drive the Company Culture

You combine strategic thinking with the ability to execute, both individually and by leading teams, to achieve operational excellence in the face of challenging goals