Head Regulatory Operations
1 month ago
**Location**:
- London - White City**Job Summary**:
**Role Summary**
With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Head of Regulatory Affairs Operations & Compliance to join the Autolus team to expand their cell and gene therapy products. Autolus is looking for a Regulatory Operations Leader with proven expertise in eCTD dossier creation and oversight of publishing activities. Experience with implementing regulatory systems and regulatory standards and procedures for dossier management, publishing, archiving and submission processes is preferred.
Key Responsibilities
- Responsible for creating all regulatory submissions in a timely manner together with the regulatory operations team, in collaboration with other regulatory affairs team members, meeting health authority requirements and guidelines from regulatory operation perspective.
- Ensure solid regulatory operations system infrastructure is available to serve global regulatory affairs activities in compliance with global regulatory requirements. Effectively plan eCTD dossier creation, oversight of publishing activities, submission, tracking and archiving to achieve submission excellence and ensure regulatory compliance.
- Proactively lead regulatory operations team in a collaborative and supportive manner. Ensure regulatory operations project assignments enable timely and high quality regulatory submissions. Oversee direct reports in preparation and management of their responsibilities and assist as needed.
- Provide regular performance and activity oversight, develop relevant KPIs to monitor activities ensuring high level quality delivery in a timely manner.
- Serve as regulatory operations contact to regulatory health authorities.
- Manage and implement regulatory systems and processes to ensure achievement of submission excellence and regulatory compliance. Provide input in data migration, update/configuration requirements, integration strategies and change management needs for new and existing systems.
- Develop creative and thorough regulatory operations strategy in collaboration with Global Head Regulatory Affairs based on business needs.
- Assess and develop regulatory compliance architecture further, including required processes and ensure implementation. Contribute to Inspection Readiness and provide support to Audits and Inspection activities.
- Responsible for having awareness of external changes in the global regulatory operations environment, assess the impact, share with relevant stakeholders and implement required changes.
- Ensure training and development for the regulatory operations team.
- Ensure oversight and/or management of contractors & vendors, including responsibility that outsourced activities are delivered on time and on budget, address any risks proactively and transparently.
- Identify potential global regulatory risks to the strategic / operational plans and propose options to mitigate risks.
- Prepare and track regulatory operations budget.
- Leading team initiatives or department initiatives.
-
Regulatory Specialist
4 days ago
London, United Kingdom VRS Regulatory Full timeJoin the regulatory affairs team at a global pest control products company.nFriendly and experienced teamnWork on compliance and registrations for a global portfolio of products.Duties will be varied and will include biocide product registrations / notifications, gathering data, compiling dossiers, liaison with testing teams, SDS authoring, classifications,...
-
Head of Regulatory
1 day ago
London, United Kingdom The Foodie Recruiter Ltd Full timeHead of Regulatory (Food Industry) THE ROLE This is a key leadership role for a highly regarded international regulatory partner, providing the food industry - including leading retailers and market-leading manufacturers, with world-class regulatory and compliance mentoring, guidance and support, locally in the UK and internationally. The Head of Regulatory...
-
Head of Quality
1 month ago
London, United Kingdom TEC PARTNERS LIMITED Full time**Head of Quality & Regulatory Affairs** TEC Partners are pleased to be recruiting a Head of Quality & Regulatory Affairs for a high growth, next generation med tech company. My client have developed several ground-breaking technologies which address global needs for high throughput laboratoryand remote testing. Your responsibility as the Head of Quality &...
-
Operational & Regulatory Support
3 days ago
London, United Kingdom Prime Personnel UK Full timeAn international Bank is seeking a dynamic individual to join its busy Operations area as 1LoD regarding regulatory risk reporting on a 1-year maternity cover.Your responsibilities will include: * Assisting the Head of Operations to ensure the team meet the regulatory requirements/internal policies * Reviewing/analysing upcoming regulatory compliance...
-
Head of Regulatory Affairs
4 days ago
London, United Kingdom The People Co. Full timeHead of Regulatory AffairsRead the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.RemoteUp to £80,000 plus packageThe Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The...
-
Head of Regulatory Affairs
5 days ago
London, United Kingdom The People Co. Full time €80,000Head of Regulatory Affairs Remote Up to £80,000 plus package The Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Regulatory Affairs
5 days ago
London, United Kingdom The People Co. Full timeHead of Regulatory AffairsRemoteUp to £80,000 plus packageThe Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Regulatory Affairs
4 days ago
London, United Kingdom The People Co. Full timeHead of Regulatory AffairsRemoteUp to £80,000 plus packageThe Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Regulatory Affairs
4 days ago
London,, UK, United Kingdom The People Co. Full timeHead of Regulatory AffairsRemoteUp to £80,000 plus packageThe Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Regulatory Affairs
5 days ago
London, United Kingdom The People Co. Full time €80,000Head of Regulatory Affairs Remote Up to £80,000 plus package The Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Operations
1 month ago
London, United Kingdom First Tram Operations Full time**Who are we?** Tram Operations Limited (TOL) is a FirstGroup subsidiary that is proud to operate the London Trams service for Transport for London (TfL). The tram service with its 39 tramstops provides inter-urban, cross-borough services, in Southwest London, for customers travelling between Wimbledon and New Addington or Beckenham Junction and Elmers End...
-
Head of Operations
1 month ago
London, United Kingdom First Tram Operations Full time**Who are we?** Tram Operations Limited (TOL) is a FirstGroup subsidiary that is proud to operate the London Trams service for Transport for London (TfL). The tram service with its 39 tramstops provides inter-urban, cross-borough services, in Southwest London, for customers travelling between Wimbledon and New Addington or Beckenham Junction and Elmers End...
-
Head of Regulatory/Regulatory Partner
1 month ago
London, Greater London, United Kingdom EJ Legal Full timeI am working with a leading European law firm which has a strong international presence and is looking to bring on a Regulatory Partner/Head of Regulatory to join its existing Regulatory practice, which specialises in life sciences regulation for UK and European clients. Life sciences is a core industry focus for the firm and continues to be an area it is...
-
Head of Regulatory Reporting
5 days ago
London, United Kingdom Brewer Morris Full timeI am working with the UK subsidiary of a well established international Private Bank. They are currently going through a period of growth and as a result are looking to hire a Head of Regulatory Reporting which will report to the Head of Finance. Due to the firm being a Small/Medium sized business, the role will have varied responsibilities. Ideally this...
-
Head of Regulatory Reporting
3 days ago
London, United Kingdom Brewer Morris Full timeJob Description I am working with the UK subsidiary of a well established international Private Bank. They are currently going through a period of growth and as a result are looking to hire a Head of Regulatory Reporting which will report to the Head of Finance. Due to the firm being a Small/Medium sized business, the role will have varied...
-
Head of Regulatory Reporting
5 days ago
London, United Kingdom Brewer Morris Full timeI am working with the UK subsidiary of a well established international Private Bank. They are currently going through a period of growth and as a result are looking to hire a Head of Regulatory Reporting which will report to the Head of Finance. Due to the firm being a Small/Medium sized business, the role will have varied responsibilities.Ideally this...
-
Head of Regulatory Reporting
5 days ago
London, United Kingdom Brewer Morris Full timeI am working with the UK subsidiary of a well established international Private Bank. They are currently going through a period of growth and as a result are looking to hire a Head of Regulatory Reporting which will report to the Head of Finance. Due to the firm being a Small/Medium sized business, the role will have varied responsibilities. Ideally this...
-
Head of Regulatory Affairs
4 days ago
London Area, United Kingdom The People Co. Full timeHead of Regulatory AffairsRemoteUp to £80,000 plus packageThe Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Regulatory Affairs
4 days ago
London Area, United Kingdom The People Co. Full timeHead of Regulatory Affairs Remote Up to £80,000 plus package The Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...
-
Head of Regulatory Affairs
4 days ago
London Area, United Kingdom The People Co. Full timeHead of Regulatory AffairsRemoteUp to £80,000 plus packageThe Company and Role. A trusted partner within the food and consumer good market this progressive business work with a range of customer globally. The business currently seeks a highly skilled and experienced regulatory expert to play a key leadership role in navigating through the intricate...