Technical Regulatory Team Member in Basel

veröffentlicht
Kontakt
Barbara Sorce, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Basel, Basel-Stadt
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
15442
Kontakt
Barbara Sorce, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

For our client, a pharmaceutical company in Basel we are looking for a   Technical Regulatory Team Member •       Start date: 01.03.2021•       Latest start date: Max 1 month notice period•       End date: 6 months duration•       Extension: possible•       Work location: Basel•       Workload: 100%•       Remote/Home Office: Home office at the moment•       Travelling: noBackground:In the role of Technical Regulatory Team Member (TRT), you are contributing to the development and execution of regulatory strategies, the sustainment of regulatory compliance at manufacturing sites, and the representation of PTR within internal functions and external groups. The focus of the TRT is on enabling global CMC-development leading to successful global commercial registration and/or effective management of post-approvals changes and product lifecycle including dossier preparation.This role deals with the technical regulatory part of the submission dossier, ensuring the proper regulations are followed for the manufacturing of active substance and tablets. This is within PTR, NOT PDR (not dealing with clinical regulations). Main countries are US, EU & I7/8. It is an operational role where main tasks includes writing, review and coordinating RA documentation. The perfect candidate is someone with around 5 years in a similar environment: experience with technical regulatory affairs, with CMC regulations and Health Authority management. Tasks & Responsibilities: •       Responsible for submission of high quality CMC regulatory documents to health authorities in accordance with current Good Manufacturing Practices (cGMP), Roche corporate standards and the requirements of applicable health authorities and other regulatory agencies.•       Contributing to the timely regulatory approval of Roche products.•       Actively contribute to the success of the technical regulatory team (TRT) objectives.•       Support the development and communication of the regulatory strategy to ensure cross-functional alignment.•       Help ensure cross-functional coordination and escalation, as needed.•       Ensuring cross-functional PTR deliverables (including assignments delegated by TRL) are completed compliantly, accurately, thoroughly and in a high quality and timely manner.•       Keeping TRL fully apprised of project status and potential submission risks and impact to defined regulatory strategies and timelines.•       Managing regulatory aspects of change control and ensuring appropriate communication to TRT team regarding management of technical changes. Provide regulatory support for relevant quality systems  such  as  change  control,  discrepancy  management,  as  well  as  Health  Authority inspection support as required and/or serving as a liaison with the local health authority on behalf of the site.•       Contributing to regulatory excellence by identifying opportunities, mitigating risks and supporting continuous improvement.•       Supporting TRT team in making clear decisions.•       Supporting product related maintenance and Quality System activities as assigned (e.g., health authority commitments, health authority inspections, discrepancy assessments)•       Support departmental business processes to document and improve best practices and work efficiencies.•       Serving  as  TRL  designate  or  PTR  regulatory  compliance  representative  as  requested  by representing PTR on site, cross-functional, or leadership teams and boards (e.g., TPT/TDT, RAFT, RAC, GEG, QRB, Quality Council, Quality Leadership Team).•       As applicable: Coordinate submission as Submission Lead or Section LeadMust haves:•       5 years’ of experience in pharma in Technical Regulatory Affairs (****)•       Degree in chemistry or pharmacy or biology (****)•       Hands on experience in the technical part of the dossier (dealing with CMC regulations) (****)•       Health Authority management, extensive knowledge of regulations and guidelines of major regions (e.g. ICH, FDA, EMA, WHO) (****)•       Used to global matrix environment (****)•       Proficiency with a wide range of data/information (CMC, clinical, non-clinical safety, DMPK, quality, manufacturing, business operations in this area)•       Fluent in written & spoken EnglishNice to have:•       Experience participating in global product teams is a plus.