Manager, Regulatory Operations

Location: London, UK

Reporting to: Head of 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. We are currently recruiting for a Manager, Regulatory Operations to join the regulatory team in order to help plan, manage, track and file the multiple forthcoming submissions, including IND, BLA and MAA filings. The Manager will also support users of Orchard's document management system and health authority portals.

Key Elements and Responsibilities

The Manager, Regulatory Operations will be responsible for:

· Submission management, i.e. assisting the Regulatory Leads in preparing regulatory submission packages, gathering necessary source documentation for regulatory filings, and documenting them appropriately, advising on submission structure, keeping track of the planning / progress of regulatory submissions, managing external publishing and forward planning for submissions to come

· Hands-on formatting, performing QCs of published sequences, and transmitting and archiving the regulatory submissions

· Acting as a subject matter expert providing guidance on Publishing strategy, ensuring that Global Regulatory Leads are aware of new submissions guidance

· Submission process support; troubleshoot submission-related system or process issues and escalate as appropriate.

· Acting as a Business Administrator for the internal regulatory information system

· Performing basic user training for the RIM system with support from the Regulatory Operations team.

· Performing regular audit and maintenance of processes and systems to ensure consistent user experience

· Supporting regulatory users of health authority portals by acting as Portal Administrator

This is a great opportunity for an individual to build upon their regulatory operations experience within the rare disease space

Required Knowledge & experience

The ideal candidate will have knowledge and experience in the following areas:

· Strong knowledge of regulatory requirements governing submissions (mainly EU & US) and all related processes, gained from several years experience working in Regulatory Operations within either Publishing, Submission Management or Systems fields.

· Strong project management knowledge and experience of management of the preparation of regulatory submission packages, including pre/post approval lifecycles.

· Expertise in using electronic RIM systems (in particular Veeva RIMS).

· Must be highly proficient in MS Office 365 (with an emphasis on MS Word)

Skills and 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.

· 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

· Ability to work Independently

· Effective influencing and collaboration skills, team player

· Good communicator, with ability to be an effective trainer able to provide new user/refresher training on systems and processes

Education

· Strong prior experience (5 or more years) working within Regulatory Operations teams.

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.