Regulatory affair Work, Jobs in London (with Salaries)

Regulatory Scientist
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Bachelor's degree
- Computer skills
Quick apply
14d
Analyst - Regulatory Market Access and Compliance
Access Partnership —London
- Hybrid work
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Quality Assurance Officer
Medreich Plc —Feltham
- £32,000 - £35,000 a year
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
- Free parking
- Annual leave
Quick apply
Scientific Editor
WebMD —London
- Full-time
- Microsoft Office
- Bachelor's degree
- Organisational skills
Quick apply
Regulatory Affairs Associate/Manager
Transpire BIO Inc. —London
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Clinical Research Coordinator
SAVA —London
- Communication skills
Quick apply
Drug Safety Associate II
Corbus Pharmaceuticals Inc —London
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Nursing
Quick apply
6d
Communications & Policy Analyst
Milltown Partners —London
- £30,000 - £34,000 a year
- Full-time
- Hybrid work
- IT
- AI
- Communication skills
Regulatory Consultant - CMC (CMC with small molecule products)
サイネオス・ヘルス —London
- Bachelor's degree
- Contracts
Medical Information Specialist - US Hours
EVERSANA —London
- Full-time
- Remote
- Microsoft Word
- Microsoft Excel
- English
Quick apply
12d
Cyber Regulatory Engagement & Governance
State Street —London
- Full-time
- Bachelor's degree
- Financial services
- Communication skills
5d
Sr. Regulatory Affairs Officer
Milpharm Ltd —Uxbridge
- £30,000 - £38,000 a year
- Full-time
- Maintenance
- Master's degree
- Bachelor's degree
- Life insurance
Quick apply
3h
Nutrition Specialist (Global Regulatory & Corporate Affairs)
Oatly AB —London
- Part-time
- Hybrid work
- English
- Master's degree
- Travel
Quick apply
8d
Associate, Investigations, Diligence and Compliance
Kroll —London
- Full-time
- English
- Master's degree
- Bachelor's degree
5d
Quality Assessor - £60,778 - £68,422 p.a. + benefits
Medicines and Healthcare Products Regulatory Agency —London
- £60,778 - £68,422 a year
- Full-time
- Doctoral degree
- Marketing
- Presentation skills
- Annual leave
- Sick pay
1h
Analyst
Access Partnership —London
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Director, Regulatory Affairs, EU Services
Bio Pharma Resourcing —London
- £60,000 a year
- Management
- Public speaking
- Windows
Senior ESG Regulatory Operations Associate
Ralph Lauren —London
- Full-time
- Hospitality
- Organisational skills
Regulatory Affairs Manager UK&I
Medtronic —Watford
- £71,760 - £107,640 a year
- Full-time
- Analysis skills
- Project management
- Organisational skills
Associate Director, Regulatory Affairs Intelligence
Novartis —London
- £67,900 - £126,100 a year
- Full-time
- Hybrid work
- Presentation skills
- AI
- Communication skills
8d

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regulatory affair jobs near london

Regulatory Scientist

Orchard Therapeutics -
London

Quick apply

Job details

Full-time
14 days ago

Qualifications

Bachelor's degree
Computer skills

Full job description

Location: London, UK

Reporting to: Senior Director, Regulatory Science

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative cell and gene therapies. Orchard has its global headquarters in London, and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company. At Orchard, the Regulatory Science Team defines and executes regulatory strategies related to the development, registration and maintenance on the market of gene therapies (GT).

Job Summary

This role will report to the Senior Director, Regulatory Science. The successful candidate will have the opportunity to primarily work with Global and Regional Regulatory Leads who are responsible for the post-approval lifecycle management of GT products in EU/UK markets. The role will also provide an opportunity to support geographical expansion and post-approval lifecycle management of GT products in ‘Rest of World’ (RoW) markets (e.g. Middle East, Latin America, Asia Pacific countries).

This position may also provide support to the Regulatory Science team managing submissions for development programs, and/or to the Regulatory CMC team, on an ad hoc basis.

This position offers opportunities for growth and personal development in a very dynamic and innovative environment.

Key Elements and Responsibilities

Under the guidance of the Senior Director, Regulatory Science, the successful candidate will support the Global and Regional Regulatory Lead(s) in the execution of regulatory activities primarily in EU/UK markets, linked to the lifecycle management and maintenance of marketing authorisations:

Contribute to the preparation and/or review of the regulatory documentation to support the post-approval activities (variations, renewals, post-approval commitments and obligations, PSURs etc) to maintain marketing authorisations up-to-date and compliant in the assigned countries.
Contribute to the preparation and/or review of submission packages (including CMC, clinical, pharmacovigilance documents) to regulatory authorities (including EMA and national regulatory authorities) for the assigned programs.
Provide support to the Regional Regulatory Lead for the coordination and preparation of responses to questions and requests for information from regulatory authorities.
Contribute to the preparation and/or review documentation required for labelling activities (for example: update of core company data sheet (CCDS), Investigator Brochure (IB), product information documents, educational material) in the assigned countries.
Provide proactive support for product launch activities in relevant countries and support the maintenance of country-specific regulatory materials.
Partner with the Regional Regulatory Lead to provide support to local partners for the post-approval maintenance activities in assigned ROW markets.
Provide somesupport to Regional Regulatory Lead for marketing authorization applications in new ROW geographies (e.g. Latin America, Asia Pacific countries).
Monitor, analyse, and disseminate intelligence on regulatory topics that may impact approved commercial products and specific geographies.
Provide support to improve team standard operation procedures (SOPs) and to prepare internal audits and future Health Authority inspections.

Requirements

Required knowledge/experience

An early regulatory career professional who has worked in EU/UK regulatory affairs, preferably supporting post-approval life cycle management activities, within industry or regulatory consultancies.
Knowledge and understanding of EMA/MHRA requirements for preparation and submission of regulatory documentation (e.g. variations, PSUR, renewal) to support post-approval life cycle management activities in the EU/UK.
Konwledge and/or experience in marketing applications or post-approval submissions for Gene Therapy or Cell Gene Therapy products is a plus.

Skills & Abilities

Ability to work in a cross-functional, multi-cultural team environment, and with remote teams.
Strong attention to details.
Ability to handle multiple tasks in parallel and prioritise effectively.
Comfortable working in a fast paced and constantly evolving environment with an ability to adapt to program/activities changes.
Strong collaboration mindset.
Proven organisational, computer and documentation skills.
General interest in a broad range of regulatory activities

Education

BSc degree or equivalent in life sciences. An advanced degree is highly desirable.
Regulatory Affairs certification is a plus.

Quick apply

Refine Your Search

regulatory affair jobs in london

Regulatory Scientist

Analyst - Regulatory Market Access and Compliance

Quality Assurance Officer

Scientific Editor

Regulatory Affairs Associate/Manager

Clinical Research Coordinator

Drug Safety Associate II

Communications & Policy Analyst

Regulatory Consultant - CMC (CMC with small molecule products)

Medical Information Specialist - US Hours

Cyber Regulatory Engagement & Governance

Sr. Regulatory Affairs Officer

Nutrition Specialist (Global Regulatory & Corporate Affairs)

Associate, Investigations, Diligence and Compliance

Quality Assessor - £60,778 - £68,422 p.a. + benefits

Analyst

Director, Regulatory Affairs, EU Services

Senior ESG Regulatory Operations Associate

Regulatory Affairs Manager UK&I

Associate Director, Regulatory Affairs Intelligence

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