Overview of role
Alvotech’s Global Regulatory Affairs (GRA) team is dedicated to bridging science and regulatory authorities to bring affordable biosimilar medicines to patients worldwide. As Director US Agent, Policy Liaison & US-Office Oversight reporting to VP, Global Head Regulatory Science & Policy, you will play a pivotal role in shaping Alvotech´s regulatory policies with the US FDA and supporting global regulatory initiatives. This is a highly collaborative, cross-functional role that also includes oversight of the Alvotech USA Inc. office.
The position is based in Leesburg, VA, and requires a minimum of four days per week onsite to ensure effective coordination and operational support.
Scope & Responsibilities:
- Serve as the official US Agent and primary contact with the FDA for all regulatory submissions and communications, including BPD meetings, BLAs, supplements, annual reports, and other correspondence.
- Manage all inbound and outbound regulatory communications between Alvotech and the FDA.
- Act as the FDA’s interface for the foreign establishment, including inspection coordination and document handling.
- Monitor and analyze evolving US FDA regulatory policies relevant to biosimilars, devices, and combination products.
- Provide strategic insights and policy updates to the Global Regulatory Science & Policy team and senior leadership.
- Collaborate with US trade organizations and internal subject matter experts to assess policy impacts and support regulatory strategy development.
- Support the development and implementation of long-term regulatory policy initiatives aligned with company priorities.
- Oversee administrative operations of the Alvotech USA Inc. office, including handling FDA correspondence, document archiving, and managing shipping services (e.g., FedEx, DHL).
- Provide flexible support for ad hoc office needs and facilitate coordination between US and global teams.
Job requirements:
- Advanced degree in life sciences or a related field: MSc with 15+ years, or BSc with 20+ years of relevant experience in the pharmaceutical or biotechnology industry. A PhD is a strong advantage.
- Extensive Regulatory Affairs experience, with deep expertise in biologics and US drug development processes.
- Proven track record of leadership and a strong background of interactions with the FDA.
- Excellent verbal and written communication skills, with the ability to convey complex regulatory concepts clearly.
- Fluency in English and strong interpersonal skills to collaborate effectively across diverse, cross-functional teams.
- Comfortable working in a global organization, with the majority of colleagues and stakeholders located outside the US.
- Strong organizational and multitasking abilities, with experience managing multiple projects simultaneously.
- Skilled in coordinating and leading virtual meetings between the FDA and internal global teams.
What we offer:
- An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
- The chance to be a part of a global and fast-growing company.
- An international work culture that encourages diversity, collaboration and inclusion.
- Positive, flexible, and innovative work environment.
- Support for personal growth and internal career development.
- Internet at home for full-time employees.
Why Alvotech
At Alvotech, we are passionate about improving lives by increasing access to affordable biologics. We’re purpose-driven and committed to fostering an inclusive and diverse working environment that encourages curiosity, ingenuity and simplicity. We want our employees to feel inspired in their careers, challenged by interesting and meaningful work and empowered to succeed in an agile environment.
True to our Icelandic roots, we also believe that integrity, gender equality, and fairness are foundational. We strive to bring together the brightest minds regardless of backgrounds and beliefs, to deliver to our partners and patients around the world. Let’s create a healthier world together, through affordable biologic medicines.
