Nieuwe vacature:
Regulatory Affairs Manager
Department:
The regulatory department of Pharming is a small department staffed with professionals working on the different RA submissions and regulations. The marketing of Pharming’s product Ruconest is expanding, and the amount of regulatory affairs along with it. Therefore we need an additional team member with CMC knowledge, preferably in the field of biotherapeutics. In this position you will report to the senior director regulatory affairs and work in close cooperation with other departments.
Job description:
The Regulatory Affairs Manager will be responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registration. He/she may represent the department on multidisciplinary teams. Additional responsibilities will include involvement in the writing and oversight of regulatory submissions, coordinating all aspects of paper and electronic regulatory submissions, proactively keeping updated on regulatory requirements worldwide, and distributing regulatory intelligence to the internal teams.
Tasks & responsibilities:
• Work with RA director to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Regulatory documents may include the relevant forms, meeting requests, Briefing Documents for meetings with health authorities, new Clinical Trial Applications (CTAs, INDs, IMPDs), Marketing Applications, and any amendments thereto.
• Develop detailed regulatory project plans and support regulatory activities relating to Pharming’s portfolio of products/projects.
• Participate as an active team member and provide strategic regulatory advice to project teams as required.
• Coordinate responses to regulatory authorities’ questions with strict deadlines.
• Serves as a liaison between internal departments at Pharming, and external parties
• Maintains regulatory files in a format consistent with internal requirements.
•Regulatory Intelligence: Keep ahead of US FDA, EMA and rest of the world regulatory requirements and changes within the regulatory registration processes. He/she advises the director on future International regulations, based upon thorough knowledge of applicable regulations.
•Develops and executes plans and timelines for product and process approvals.