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Regional Regulatory Practice Area Lead

3 months ago

Malvern, United States PharmaLex Full time
Job DescriptionJob DescriptionRegional Regulatory Practice Area Team Lead, Reg SPM and Reg CMC
Role purpose
  • Team 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.
  • Responsible for implementing operational tasks, derived out of global business development efforts, including management of large customer projects, in the field of regulatory affairs
  • Leads assigned business development and recruitment activities, in collaboration with, and with agreement from, the global Head of VDC REG and Practice Area Leads.
  • Through leadership, facilitate continued growth in the regional/local REG service domain/business, in collaboration with the General Managers, Regional Sales Managers, other regional/local Practice Area team leads (promoting cross-selling) and through appropriate delegation and monitoring execution of expansion within designated priority accounts.

Main tasks
  • 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.

Key Decisions made by this role
  • Decisions concerning the departments’ strategy in agreement, where appropriate, with the Head of VDC, Practice Area Leads and Country/Regional General Managers (if applicable).
  • Initiation of collective agreement actions (e.g., warning, dismissals of employment contracts) in agreement with the Head of VDC REG, General Manager and Human Resources department.
  • Decisions regarding suitability of project approaches and solutions.
  • Budgetary estimates for business development activities in collaboration with Commercial.

Critical qualifications, experience, ‘know-how’ and skills – preferred set
  • 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.

 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.

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