Categoria: Regulatory Affairs Manager
Pharmaplanet seeks a Regulatory Affairs Associate Director to integrate a renowned company in the Pharmaceutical Industry.
• Establish and maintain excellent working relationships with client companies and their personnel.
• Advise clients on regulatory strategy and fit this to the client’s overall business objectives, as well their financial, resource and time constraints.
• Prepare, submit and gain approval of regulatory applications to Regulatory Agencies.
• Interpret and respond to regulatory questions to resolve issues.
• Assess scientific data and prepare scientific documents to support regulatory applications.
• Influence key players in the regulatory process, including Regulatory Agencies.
• Plan, manage and execute projects and monitor progress to meet defined objectives and timescales.
• Draft and review all types of regulatory documentation.
• Develop and maintain a thorough knowledge of European and EU national regulatory requirements.
• To identify and assess emerging regulatory intelligence and to share this information with other colleagues and clients in a timely manner.
• To account manage clients, and build and maintain strong working relationships with client company personnel.
• To actively contribute to monthly team meeting discussions.
• Be flexible to respond to client demands.
• Maintain the Company’s philosophy and work ethos.
• Support with the preparation of project proposals and cost estimates.
• Effectively delegate projects to team members, when required.
• Successful completion of a Master’s Degree or equivalent in pharmacy or other natural sciences
• Extensive professional experience in evaluation, preparation and compilation of regulatory documents, quality documentations and/or extensive experience in regulatory processes (registration procedures, renewals, variation procedures)
• Autonomous, concentrated and high-quality work
• Ability to deliver and effectively manage strategic goals for the business as well as strategic goals of partnerships with clients; ability to balance client requests, employee and company interests
• Strong understanding of the business economical areas to adequately prepare and/or support the preparation of proposals/RFP responses for clients
• Structured, analytical, systematic and independent way of working
• Ability to adjust rapidly to new, unknown, challenging situations; delivery of strategic outputs and actions consistent with operating policies
• Lead extensive process reengineering activities and provide consultation related to change management
• Proactively identify and manage up/cross selling opportunities
• Ability to analyse problems and propose solutions at a business level
• Ability to lead large and/or complex project teams, distribute work equally and according to team member's strengths, developing and motivating both junior and experienced colleagues; convincing others in difficult change management situations
• Ability to work in a team
• Ability to manage internal and external client relationships on client's department head level; ability to convey strategic goals of collaboration and be an ambassador for the company.
• Excellent communication skills (written and verbally)
• Proven capability to communicate critical issues, analyse and propose appropriate solutions to decision makers and business heads.
• Excellent presentation skills
Integration in a renowned company in the Pharmaceutical Industry;
Continuous development opportunities through knowledge and experience as well as training.
Submit your application through our website Planetmais.pt