Records & Information Manager
Records & Information Manager
Switzerland, Basel-Town, Basel
Canada, Ontario, Mississauga
United States, California, South San Francisco
The records Information Manager in Regulatory Affairs is responsible for the dispatch of registration dossiers to Health Authorities and Roche Affiliates worldwide on a product responsible basis. (applicable for EU/RoW Dispatch-RecIM only). Furthermore, the Records Information Manager is responsible for creating the planning of a submission in the Global Product Regulatory System (GPRS) based on the product responsible. After dispatch and on a regional basis, the main responsibility of the empoyees is to ensure the accuracy of the Registration data, proactively monitoring data compliance and updating the registration status details. The daily tasks are performed according to Roche Operation Standards and in close collaboration with the DRA affiliates worldwide. Additionally, the Records Information Manager has to provide support to internal and external audits and inspections, new legislation, act as GPRS primary contact to global and local stakeholders, projeect teams and DRA affiliate members for all questions pertaining to the retention and retrieval of regulatory records. Provide oversight of external business partners and vendors.
The senior RecIM should be able to lead or co-lead a specific project. The project needs a successful implementation and benefit to the RecIM group as well as the Company.
Key Responsibilities and Tasks:
- Act as a product responsible,
- Based on the PDRO Activity Sheet, create a planning entry in GPRS and enter the registration details as applicable,
- Co-ordinate copying and dispatch of regulatory documents to Health Authorities and Roche Affiliates world-wide in collaboration with regulatory product managers and concerned functions (applicable for EU/RoW Dispatch-RecIM only),
- Ordering, storage, tracking and dispatch of country specific elements such as galenical samples, reference standards, packaging material, certificates) for registration purposes (applicable for EU/RoW Dispatch-RecIM only),
- Upon dispatch of the submission, instruct TCS to proceed with the archiving in GPRS,
- As a regional data responsible,
- Proactively monitor Regulatory compliance in GPRS,
- Ensure registration data is tracked in GPRS and update the registration status details to align with local approval information,
- Support data cleaning in close collaboration with the respective DRA affiliates to ensure data quality,
- Act as a Subject Matter Expert (SME) for a specific activity on data management or dispatch.
Who you are
You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.
- Demonstrated project management skills,
- Demonstrated quality focus,
- Strong customer focus,
- Good communicator with members of cross-functionnal teams,
- Understanding of the drugs development processes (medicines terminology),
- Good understanding about standard records management requirements,
- Excellent organizationnal skills to meet aggressive dispatch timelines,
- Shows initiative to improve and optimize current working processes,
- Interpersonal/Teamwork Skills: works effectively as a team member in matrix-based environment to produce high quality output.
The statements made in this job description are intended to describe the general nature and level of work being performed by those persons assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
Who we are
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
- Location Switzerland, Basel-Town, Basel | Canada, Ontario, Mississauga | United States, California, South San Francisco
- Function Regulatory Affairs
- Subfunction Drug Regulatory Affairs
- Schedule Full-time
- Job level Individual Contributor
- Job type Regular Employee
- Division Roche Pharmaceuticals
- Date 2016/11/30
- Job-ID 3237805053