PharmaLex is hiring a
Regulatory Practice Area Lead, Remote - Worldwide

Summary

The job is for a Regional Regulatory Practice Area Team Lead responsible for leading regional teams in Regulatory Strategy and Procedure Management (SPM) and Regulatory CMC (CMC). The role involves business development, project management, team leadership, and strategic decision-making.

Requirements

• Degree in Life Science
• At least fifteen years of experience in pharmaceutical regulatory affairs
• Proven experience in managing cross-functional and cross-country projects, including basic economic knowledge and experience to efficiently and effectively steer the dedicated projects
• Proficient leadership qualities, motivational skills and ideally already experienced in leading executives
• Capability to coordinate different projects to be executed in parallel
• Resilience, willingness to work a flexible schedule and travel
• Excellent interpersonal skills
• Excellent written and verbal communication skills
• Self-confidence and assertiveness
• Confidence to work alone as well as in a team
• Strategic, analytical and structured thinking
• Ability to assimilate and analyze information rapidly
• Ability to identify and offer solutions to problems in a pragmatic way
• Ability to adjust rapidly to new, unknown, challenging situations
• Fluent in English

Responsibilities

• Leadership of regional Practice Area teams for Regulatory Strategy and Procedure Management (SPM) and Regulatory CMC (CMC)
• Active participation in the development and management of the Regulatory Affairs (REG) department within the Value Delivery Centre (VDC) REG, in relation to the SPM and CMC Practice Areas
• Implement operational tasks derived out of global business development efforts, including management of large customer projects, in the field of regulatory affairs
• Lead assigned business development and recruitment activities, in collaboration with, and with agreement from, the global Head of VDC REG and Practice Area Leads
• Support marketing and business development activities for regional clients for all existing REG SPM and CMC Services, in collaboration with Practice Area Leads
• Support Commercial/General Managers to acquire new customers (RfP coordination, participation in bid defense meetings)
• Drive major new regional/local client programs, including implementation and continuous improvement of budget, KPIs and other project management tasks
• Communicate and implement decisions of the REG VDC office within the regional team
• Represent departmental interests towards the REG VDC office, including generation, management and reporting on REG country budget, order pipeline and other financial and HR figures
• Participate in staffing proposals and decisions for projects within the region and ensure utilization of local/regional resources by collaborating with Practice Area Leads in staffing decisions
• Operational steering of the regional Practice Area team
• Lead and coach dedicated employees; conduct probation period, annual employee evaluations and goal setting meetings where applicable
• Form leadership culture within the team in close cooperation with the REG VDC and the General Managers
• Represent the company and department towards clients, authorities and associations
• Lead the local/regional team to ensure sufficient resourcing across project; consistently implement processes within the region; and continue to develop their ability to deputize/take appropriate self-initiative as the role holder’s job scope diversifies