Associate Director, European Regulatory Affairs at Veristat | Torre
Associate Director, European Regulatory Affairs
trending_up Invest in Torre
Veristat

Associate Director, European Regulatory Affairs

Veristat
Posted by
Manuela Vargas Jaramillo
Emma highlights
This highlight was written by Emma’s AI. Ask Emma to edit it.
Full-time

Legal agreement: Employment

Compensation
USD69k - 150k/year
Non-negotiable
location_on
Hybrid (United Kingdom)
Posted almost 6 years ago

Responsibilities

• Be responsible for the direct management of European Regulatory Affairs managers and assigned staff, and indirect management of all European Regulatory Affairs staff including performance management, career development, training, and employee relations • Be responsible for resourcing and project staffing, with support from Leadership. Therein, assists with assessing hiring needs, interviews, compensation, and hires to align with the needs of the department • Be responsible for participating in the creation and provision of strategic direction and leadership to the European Regulatory Affairs department to best achieve departmental and company goals. In conjunction, s/he also participates as a member of the Senior Leadership Team • With support from Leadership, responsible for department financials - profit and loss (P&L), including participation in corporate revenue recognition activities and senior leadership meetings related to European Regulatory Affairs • Provide consulting services in regulatory program strategy, overall drug development plans, strategic regulatory communications and health authority representation • Author, direct and provide strategic guidance to regulatory submissions worldwide, with a special focus on EMA submissions (MAA, IMPD; both original applications and amendments) • Prepare clients for health authority meetings, and as contracted, serve as legal representative • Write, review and provide strategic regulatory guidance on alternative pathways such as orphan, PRIME, and conditional marketing authorization • Represent European Regulatory Affairs in business development activities by developing project bid proposals, participating at bid defense & governance meetings, performing client presentations, and participating in external events to elevate Veristat’s industry presence, to act as a thought leader.
This job post is closed.