Regulatory Affairs Specialist
Info Terbaru Seputar Pekerjaan dari Perusahaan Alimentiv sebagai posisi Regulatory Affairs Specialist. Jika Lowongan Kerja Sales di Departamento de Cerro Largo ini sesuai dengan kriteria anda silahkan langsung mengirimkan lamaran / CV Terbaru anda melalui situs loker terkini dan terupdate Lokerindo.ID
Setiap pekerjaan mungkn tidak lah mudah untuk di lamar, karena sebagai kandidat baru / calon pegawai harus memenuhi beberapa kualifikasi dan persyaratan sesuai dengan kriteria yang dicari dari Perusahaan tersebut. Semoga info karir dari Alimentiv sebagai posisi Regulatory Affairs Specialist dibawah ini sesuai dengan Kualifikasi anda.
Responsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools, process/document regulatory risk assessments, and provide support, expertise and represent the unit with other functional units, sponsors, researchers and/or regulatory authorities. Ensure high quality, timely service delivery processes are maintained in accordance with corporate, industry and regulatory standards and guidelines. May be required to coach peers and/or provide input for staff performance reviews.Unit Management - Coordinate the day to day delivery of regulatory services and processes, including compilation of regulatory filings/submissions/revisions for projects, third party vendors and clinical sites.
- Conduct or assist with regulatory and/or safety reviews, create regulatory-related tools, educational/training materials, and remain current on all aspects of clinical research regulatory requirements and industry best practices, communicating changes to project leaders in a timely manner.
Client Services - As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
- Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.
Regulatory Strategy Development - Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
- Participate in specialized conferences/meetings to increase knowledge as needed.
Project Support - Regularly respond to registration requests and work with project teams to identify regulatory requirements.
- Assist in the preparation of regulatory submissions and support summaries.
- Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.
Qualifications - Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
- The successful candidate will possess strong knowledge of EMA regulations.
Working Conditions - Home-based
-
- Accommodations for job applicants with disabilities are available upon request.
- As the corporate subject specialist in regulatory affairs, provide regulatory, ethics and/or pharmacovigilance guidance and support to project stakeholders.
- Represent the unit at project meetings, assisting with project education/regulatory tool development, at regulatory reviews and audits, with clients ensuring expectations are managed and met, with regulatory, ethics and government representatives and, when appropriate, respond to regulatory queries on behalf of the client.
Regulatory Strategy Development - Identify changes in clinical research regulatory requirements and industry best practices and recommend, implement, and maintain corporate regulatory strategies, working with other experts (safety, quality assurance) when appropriate, to meet or exceed compliance requirements of evolving regulatory initiatives.
- Participate in specialized conferences/meetings to increase knowledge as needed.
Project Support - Regularly respond to registration requests and work with project teams to identify regulatory requirements.
- Assist in the preparation of regulatory submissions and support summaries.
- Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.
Qualifications - Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
- The successful candidate will possess strong knowledge of EMA regulations.
Working Conditions - Home-based
-
- Accommodations for job applicants with disabilities are available upon request.
- Regularly respond to registration requests and work with project teams to identify regulatory requirements.
- Assist in the preparation of regulatory submissions and support summaries.
- Ensure project/clinical site files and documents are developed, maintained, revised, archived and/or destroyed in accordance with project and regulatory requirements and that all project stakeholders are fully informed and trained on all applicable regulatory requirements.
Qualifications - Applicants should have a minimum of an undergraduate degree and 4-6 years of relevant experience in Clinical Research/Regulatory Affairs.
- The successful candidate will possess strong knowledge of EMA regulations.
Working Conditions - Home-based
-
- Accommodations for job applicants with disabilities are available upon request.
- Home-based
-
- Accommodations for job applicants with disabilities are available upon request.
Informasi Tambahan :
- Perusahaan : Alimentiv
- Posisi : Regulatory Affairs Specialist
- Lokasi : Departamento de Cerro Largo
- Negara : UY
Cara Mengirimkan Lamaran :
Setelah Membaca dan telah mengetahui kriteria dan kebutuhan minimum kualifikasi yang telah dijelaskan dari info pekerjaan Regulatory Affairs Specialist di kota Departamento de Cerro Largo diatas dengan demikian jobseeker yang merasa belum memenuhi persyaratan meliputi pendidikan, umur, dll dan memang merasa berminat dengan lowongan kerja terbaru Regulatory Affairs Specialist, pada bulan ini 2025 diatas, hendaknya secepatnya untuk melengkapi dan menyusun berkas lamaran kerja seperti surat lamaran kerja, CV atau daftar riwayat hidup, FC ijazah dan transkrip dan pelengkap lainnya seperti yang telah dijelaskan diatas, guna mendaftar dan mengikuti seleksi masuk penerimaan pegawai baru diperusahaan yang dimaksud, dikirim melalui link Halaman Selanjutnya di bawah ini.
Perhatian - Dalam proses rekrutmen, perusahaan yang sah tidak pernah menarik biaya dari kandidat. Jika ada perusahaan yang menarik biaya wawancara, tes, reservasi tiket, dll hindari karena ada indikasi penipuan. Jika Anda melihat sesuatu yang mencurigakan, silakan hubungi kami: support@lokerindo.id
Tanggal Tayang : 2025-01-10