Regulatory Manager - UBC
Company: United BioSource Corporation.
Location: London, United Kingdom
Closing Date: 23 Jan 17
Type: Full Time
Salary (£): Competitive
Benefits: Comprehensive Package
Responsible for process implementation and ensure process compliance within the EU Regulatory Operations team.Provide project management oversight (tracking, planning, timelines) for Regulatory (MOH) submissionsCreate high quality reports and other outputs according to the defined specifications to ensure timely reporting of team metrics to senior management.To ensure that new studies are registered correctly and in a timely fashion.
Since 2003, UBC has been the home for people who are passionate about innovation, service and making a difference in peoples' lives and in the healthcare and biotech industries. As a service organization, UBC employees are our greatest resources. Their skills and expertise are what sets us apart in the industry.
Working here, you will support the development of life-changing therapies. You will work with peers who will become friends and leaders who listen to your feedback in a collaborative, innovative and fast-paced culture. You will enjoy competitive benefits, pay-for-performance compensation and rewarding recognition that promotes internal quality and critical alignment of our business objectives. And finally, you will enjoy the vast network of resources of our Fortune 20 parent organization, Express Scripts.Brief Description:
The primary responsibility of this role is the creation of regulatory documents and development of regulatory strategy to achieve regulatory approvals and clearances worldwide expediently and consistently within all studies, interventional and non-interventional.
Specific Job Duties:
- Responsible for process implementation and ensure process compliance within the EU Regulatory Operations team.
- Provide project management oversight (tracking, planning, timelines) for Regulatory (MOH) submissions
- Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of team metrics to senior management.
- To ensure that new studies are registered correctly and in a timely fashion.
- Develop the regulatory application strategy, including the data requirements, costs and time schedules necessary to achieve global project approvals as required by the project plan in a timely and cost-effective manner.
- Ensure the provision of robust scientific information to support key sponsor regulatory project milestones (e.g., ensure that all state and federal regulatory requirements are addressed for the clinical research program and for marketed products).
- Serve as world-wide technical expert, on relevant regulatory issues potentially impacting the study. Defend UBC and/or Sponsors’ approach at local, regional or international forums where science- based harmonized approaches may be influenced and promoted.
- Propose, in line with the business timelines, the 1-5 year regulatory studies and activities budget, specifying quality standards to be met, and making best use of UBC’s resources. Contribute to the creation and updating of robust Project Plans and whenever required, provide feedback to such teams on achievements and bottlenecks.
- Develop professional relationships with MoH staff and proactively monitor relevant governmental bodies to identify changes in legislation/regulations.
- Provide regulatory expertise to clinical project teams (e.g., CTA applications, importation of clinical trial material, reporting of adverse events).
- Provide country specific regulatory expertise to global product development teams.
- MSc degree or the equivalent in a scientific discipline plus 3-5 years’ regulatory experience pertinent to clinical trials, non-interventional studies and/or registries.
- Preparation and submission of CTAs, the applications for import licenses, and any reporting procedures, e.g, SAE reporting obligations and procedures.
- Recognized expertise in regulatory affairs and good understanding of scientific as well as political dimension.
- Fluent in English.
- Very strong organization, planning and budget tracking abilities to handle potentially conflicting multiple portfolio projects.
- Strong leadership abilities to unite diverse groups to a common task and strategy.
- Excellent verbal and written communication skills to collaborate with and discuss technical information and regulatory requirements with project teams and governmental agencies.
- Expertise with information management technology (e.g., archiving databases, document editing software, statistical manipulation of data).
- Demonstrated networking ability and negotiation skills to work within sponsor and government systems building expert networks and applying them to address business needs.
- Ability to work effectively with lengthy project review periods.
- Flexibility, adaptability, diplomacy, and ability to overcome complexity.
- Respect for and understanding of cultural diversity.
- Ability to work with all levels of management.
- Ability to travel internationally and domestically.
- General computer proficiency including Microsoft Word, Excel, Access, Internet, and experience with document tracking tools.
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