On behalf of our client, an international Biotechnology company based in Bern, Swisslinx is looking for a Senior Regional Regulatory Affairs Specialist. This is a 6-months contract position (extension possible) with a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
- Start date: 01/11/2022 - Duration: 6 months - Extension: possible - Work location: Bern - Workload: 100%
You will support regional regulatory tasks for a range of investigational and licensed products in one Regional Therapeutic Area. This role involves working closely with Regional Regulatory Managers, Scientists or Therapeutic Area Leads primarily on operational activities and projects. The Senior Specialist will support the Global Regulatory Affairs (GRA) vision of excellence through good scientific practice, integrity and consistent compliance with regulatory standards. The incumbent closely cooperates with specialists of other GRA functions at the same or at other sites. The incumbent may establish and maintain effective working relationships with respective Regional / Local Regulatory Managers of Affiliates or Regulatory Agents, as required.
- Support the compilation and submission of high quality documentation such as new license applications, change applications, labeling submissions, license renewals, clinical trial applications/INDs, pediatric plans, orphan drug designations, product identifiers/names, tenders, periodic reports, health authority meetings etc. in accordance with agreed schedules, taking into account regional specific requirements. - Support in the strategy, planning and preparation of health authority documents. - Assist in reviewing technical and/or scientific information for compliance with regional regulatory requirements and interpretations, identifying deficiencies and when needed, proposes solutions to remediate the risks. - Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines, i.e., investigate country specific regulatory requirements regarding layout, structure and dossier type (eCTD, NEES, pdf, etc.). - Provide dossier operational support to the Regional Regulatory Manager or Scientist and Therapeutic Area Lead for the creation of regional documentation (e.g. Module 1 documentation) to ensure timely submission - Assist the Regional Regulatory Manager or Scientist in managing regulatory procedures in the region - Upon request, support collection of Regulatory and Competitive Intelligence Information by monitoring HA and competitor sites (e.g., labeling, SBORA) and prepare comparative materials. - Upon request, assist in the coordination of the regulatory guideline review process
- Bachelor in Science-Related Discipline or 3 years apprenticeship as Medicinal Documentation Professional or equivalent. An advanced degree in scientific discipline would be beneficial - Function-related training in Regulatory Affairs - At least 3 years professional experience in Regulatory Affairs - Basic knowledge of drug development, or paramedical, and/or biological sciences - Experience with, or demonstrated ability to learn new regulatory requirements - Effective communication skills, both written and verbal - Strong organizational and problem solving skills, with the ability to prioritize workload with limited instruction - Flexibility to work independently and in teams in a global matrix organization - Strong interpersonal skills with a demonstrated ability to develop collaborative, constructive and effective relationships - Microsoft Office, Documentum, etc. - Fluent in English
To apply or for any further information, please do not hesitate to contact Alina Peeva, recruiter: firstname.lastname@example.org By applying for this position, I consent to the Swisslinx Group of companies: - storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities - using my personal information or - supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities - transferring where applicable my personal information to a country outside the EEA/EFTA