Location: Remote/London, UK
Reporting to: Director, Regulatory Operations
Job summary
Orchard Therapeutics is a leading global fully integrated commercial and clinical-stage company dedicated to transforming the lives of patients with rare diseases through innovative gene therapies. As part of our on-going growth, we are currently recruiting for a Senior Manager, Regulatory Operations to join the regulatory team in order to help plan, manage and track Regulatory Process whilst also supporting the Regulatory Operations team in the day to day management of submissions.
This is a great opportunity for an individual to build upon their regulatory and process management experience within the rare disease space. The experience that can be gained in this role is truly unique and can create an excellent next step for a successful career in regulatory affairs.
Key Elements and Responsibilities
The Senior Manager, Regulatory Operations will be responsible for:
- Reviewing all internal Regulatory SOPs, Work Instructions and general processes and perform a gap analysis.
- Provide Regulatory Leadership Team members recommendations on processes improvements and better process management.
- Manage and maintain the Regulatory SOP schedule in MasterControl, ensuring that approved SOPs are reviewed and approved on time.
- Work with the Regulatory and Quality departments to improve current SOP.
- Help Regulatory and other functions with the implementation of Veeva support change management and adoption of this new tool in day-to-day activities
- Support the Regulatory Systems manager with Business Administration and systems training for the RIM system.
- Author, implement and maintain tools (e.g. trackers, templates) to ease and/or optimize regulatory processes
- Support the Publishing Manager with Vendor management.
- Support Regulatory Operation publishing activities, i.e. formatting, QC, Task-list management, timeline management and submissions dispatch.
- Provide Submission Management support ensuring that priority submissions are planned appropriately and have the right resource required to meet timelines.
Requirements
Required knowledge
The ideal candidate will have knowledge/experience in the following areas:
- Strong knowledge of regulatory requirements governing submissions and all related processes
- Strong knowledge of management of regulatory submissions including pre/post approval lifecycles for EU, US and ROW markets
- Experience of EDMS and electronic RIM systems (Veeva)
Skills amp; Abilities
The regulatory group is looking to hire an individual that has a proactive attitude and can work autonomously. Pro-activeness and autonomy are essential in this group due to the size of the team and the variety of work that the team manages on a global level.
The ideal candidate will be able to demonstrate the following skills and abilities:
- Ability to assess processes and provide recommendations for improvements
- Proven ability to initiate, implement, manage, and maintain formal departmental processes
- Ability to be an effective trainer able to provide new user/refresher training on systems and processes
- Effective organizational administrative and planning skills
- Analytical approach to work with excellent attention to detail
- Ability to work across different projects in a fast-paced environment
- Education to Bachelor’s/advanced degree level in a scientific discipline
- Strong prior experience within regulatory operations
Education
The ideal candidate would have the following academic attributes:
- Education to Bachelor’s/advanced degree level in a scientific discipline
- Strong prior experience within regulatory operations
Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.
We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.