Proclinical is hiring for a Regulatory Operations Manager based in the US. Regulatory ops/affairs are responsible for managing the logistics, preparation, quality assurance, and delivery of regulatory submissions in accordance with Regulatory agency requirements, company standards, and timelines. This position will also be responsible for participating and/or leading Regulatory Affairs systems implementation projects, including Electronic Document Management System (eDMS), publishing systems/tools.
- Lead and participate in the implementation, migration, and upgrade of regulatory systems and tools (eDMS, Regulatory Information System, CTD templates, etc.)
- Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation
- Collaborate with Regulatory Affairs and contributing functional areas to create submission project plans as well as identify and allocate internal and external resources (including vendors/CROs)
- Participate in the writing and reviewing of Regulatory processes (SOP, Work Instructions and internal guidelines)
- Apply company style guide formatting requirements to create submission ready documents that are compliant with internal and heath agency requirements
- Provides regulatory operations guidance and information to Regulatory Affairs department and submission project teams.
- Assists in the mentoring and training of Regulatory and cross-functional team members; Prepares and maintains training materials
- Leads and/or assists with other projects and activities as assigned by management to support the Regulatory Operations function, including submission compilation and publishing support.
Skills and Requirements:
- Minimum 3-5 years related experience in publishing and Regulatory Systems role within the biotechnology or pharmaceutical industry, prior experience with sterile dosage forms preferred.
- Bachelor's degree preferred; Equivalent experience within the Regulatory Operations function will be considered.
- Knowledgeable in CTD/eCTD structure and requirements and firm understanding of submission requirements for US submission types (e.g. IND, PAS, NDA, PSUR, etc.)
- Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (e.g. ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools
- Maintain familiarity with current regulatory submission standards and industry best practices. Use knowledge gained from industry teams and working groups to contribute to departmental best practices
- Demonstrated verbal and written communication skills.
- Demonstrated project management experience to include excellent organizational, prioritization and planning skills with attention to detail.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Estella Nchumuluh at [click here] or upload your Resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.