Our client is a professional Biotechnology and Pharmaceutical organization, based in Utrecht Netherlands.
Utrecht area based company is looking for an interim Regulatory Affairs Manager. This company is the specialist in Orphane Drugs.
For my client I am looking for an interim Manager Regulatory Affairs to be based in the Utrecht area. The Regulatory Affair Manager provides project management and regulatory expertise to clients developing prescription pharmaceuticals to assure their development objectives are met and compliant with applicable regulations, guidance, and laws.
Work independently to prepare and manage project plans based on global regulatory and product development strategy.
Advise clients on regulatory issues concerning their products and development programs.
Partner with client's internal teams to assure development plans align with regulatory requirements.
Coordinate team meetings with internal and external stakeholders to discuss progress on the project plan and on final client deliverables; interact with various client disciplines, such as project management, CMC, clinical, nonclinical, marketing, pharmacovigilance, Quality Assurance, business development and corporate management.
Manage new regulatory submissions, such as INDs, IDEs, NDA/ANDA/BLA, MAAs.
Supervise, guide and train associates who are part of the project team .
3-5 years of regulatory affairs or project management experience, preferably in Regulatory Affairs, within a pharmaceutical or biotechnology company environment.
Bachelors degree required, Masters or higher preferred, in a scientific discipline or closely related field
Excellent industry knowledge and familiarity with the drug development process, FDA, and EMA guidance, and the organization of the common technical document (CTD)
Strategic skills in interpretation of regulations and guidance documents
Strong written and verbal communication skills, Dutch and English Excellent organizational skills and ability to pay strict attention to detail
Experience in understanding and organizing complex scientific, technical and/or regulatory documents
Strong interpersonal skills and ability to lead and direct a multidisciplinary team
Ability to think critically and problem solve
Ability to work independently and as part of a team
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