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;
- Fixed muneration;
- Continuous development opportunities through knowledge and experience as well as training.
Please send your CV through our website Planetmais.pt
Given the expected high number of applications, it will not be operationally possible for us to provide feedback to all applicants. The selected candidates will be contacted within 15 days.