United BioSource Corporation.
*This position is available office based in London, or home based in UK, Spain, France, Germany, Italy, Netherlands and Norway.*
The primary responsibility is the management and implementation of the regulatory strategy, operational execution and creation of regulatory documents to achieve regulatory approvals and clearances worldwide across interventional and non-interventional studies. Working independently and reliably showing a high level of ownership for all assigned projects with a strong focus on detail and committed to quality deliverables to external and internal clients.
*Specific Job Duties:*
* Provide regulatory management oversight and reporting for regulatory aspects of assigned projects.
* Preparation of high quality, detailed regulatory documents using varied information sources
* Responsible for the assembly (electronic or/and paper), publishing, production, dispatch, logging and archiving of regulatory authority submissions, correspondence and approvals.
* Provide regulatory expertise to clinical project teams (e.g., CTA applications, importation of clinical trial material, reporting of adverse events).
* Responsible for highlighting potential challenges to external and internal stakeholders and advise on regulatory submissions procedures and best practices.
* Provide country specific regulatory expertise to global product development teams.
* Develop professional relationships with MoH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
* Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of team metrics to senior management.
* Educate and train project teams on regulatory submissions procedures.
* Other duties as assigned by EU Regulatory Operations Manager/designee, UBC Management or SOPs.
*Desired Skills and Qualifications:*
* Bachelor’s Degree in Life Science
* Minimum 3 – 5 years’ experience in regulatory and clinical research document management
* Previous experience in CRO/service provider or Pharmaceutical company.
* Good knowledge of the current ICH and EMA regulations related to product development in clinical trial procedures and regulations.
* Experience in timeline management for complex regulatory submissions.
* Client focused approach to work and ensure external and internal client expectations are managed and met.
* Excellent technical knowledge and understanding in the field of global regulatory operations.
* Excellent interpersonal, verbal and written communication skills.
* Excellent organizational and time management skills, with ability to handle multiple competing priorities across operating units.
* Excellent work commitment and client-focused attitude.
* General computer proficiency including Microsoft Word, Excel, Internet and experience with document tracking tools.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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