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Job Title: Associate Director - Regulatory Research & Intelligence (Maternity Cover)Work Arrangement: Hybrid (Remote with at least monthly in-office presence preferred)Contract Type: Temporary (Maternity Leave Cover)About the OrganisationThis innovative biopharma company is focused on advancing therapies for individuals living with rare and serious genetic conditions. With operations spanning North America and EMEA, the organisation is recognised for its commitment to scientific excellence and a collaborative, mission-driven culture.
Position SummaryThe Associate Director of Regulatory Research & Intelligence will be a key contributor to the development of global regulatory strategies. This role involves gathering and analysing regulatory data to support decision-making for both US and EU development programs. The position is central to ensuring that regulatory pathways, precedents, and trends are effectively leveraged to guide product development.
Core Responsibilities
- Perform comprehensive regulatory intelligence searches using public databases, agency websites, and databases.
- Monitor and interpret updates from FDA and EMA, including new proposals, approvals, and regulatory shifts
- Identify and synthesise relevant clinical trial, labelling, and approval precedents to inform strategic planning
- Collaborate closely with Global and US Regulatory Leads, as well as cross-functional teams, particularly on EMEA-focused initiatives
- Deliver insights that shape regulatory approaches across a broad and dynamic development portfolio
Candidate Profile
- Deep experience in Regulatory Intelligence within the pharmaceutical or biotech sector
- Strong background in drug development and the formulation of regulatory strategies across various therapeutic areas
- Demonstrated expertise in regulatory intelligence, including the use of specialised tools such as Cortellis
- Comfortable working across time zones, especially with teams based on the US West Coast
- Adaptable, proactive, and confident in navigating evolving priorities
Team Dynamics
This role is part of a small, focused Regulatory Research group embedded within the broader Regulatory Affairs function. The position offers opportunities to engage with Clinical Development and Asset Teams, particularly on topics relevant to the EU region.
Please forward your CV or reach out to Julia Bowden for a confidential discussion about this role and your career.
