Pharmacovigilance Work, Jobs in London, Eng (with Salaries)

Regulatory Scientist
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Bachelor's degree
- Computer skills
Quick apply
Drug Safety Associate II
Corbus Pharmaceuticals Inc —London
- Remote
- Microsoft Powerpoint
- Microsoft Word
- Nursing
Quick apply
Clinical Research Associate - Midlands
MSD —London
- Full-time
- English
- Microsoft Office
- Bachelor's degree
Medical Science Liaison - Neuroscience
Ipsen Ltd —London
- Full-time
- Doctoral degree
- English
- Master's degree
3d
Clinical Safety Coordinator
Medpace, Inc. —London
- Full-time
- Microsoft Office
- Bachelor's degree
- Medical terminology
- Annual leave
13d
Content Writer - Pharmacovigilance
RxLogix Corporation —London
- Full-time
- Hybrid work
- Bachelor's degree
- Medical terminology
Quick apply
Director, Pharmacovigilance
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Organisational skills
Quick apply
Associate Consultant - R&D Advisory
サイネオス・ヘルス —London
- Management
- Master's degree
- Business development
3d
Associate Consultant - R&D Advisory
Syneos Health Commercial Solutions —London
- Management
- Master's degree
- Business development
3d
Consultant - R&D Advisory
サイネオス・ヘルス —London
- Management
- Master's degree
- Business development
Consultant - R&D Advisory
Syneos Health Commercial Solutions —London
- Management
- Master's degree
- Business development
12 month FTC- Spanish speaking Medical Information Specialist
ProPharma Group —London
- Full-time
- Hybrid work
- Spanish
- English
- In-person
Senior Manager, Patient Safety Scientist
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Doctoral degree
- Master's degree
- Analysis skills
Engagement Manager - R&D Advisory
サイネオス・ヘルス —London
- Oracle
- Management
- Master's degree
3d
Engagement Manager - R&D Advisory
Syneos Health Commercial Solutions —London
- Oracle
- Management
- Master's degree
3d
Director, Development Unit CQA Program Lead
Novartis —London
- £78,400 - £145,600 a year
- Full-time
- Hybrid work
- Communication skills
Pharmacy Dispensing Assistant
lee pharmacy —London
- £12.75 - £13.00 an hour
- Full-time
- Medication administration
- English
- Travel
- Store discount
- Employee discount
Quick apply
12d
Associate - Inside Sales, PV Products
RxLogix Corporation —London
- Full-time
- Hybrid work
- Sales
- Marketing
- Analysis skills
Quick apply
Director Safety Surveillance & Risk Management (12 months fix term contract)
Viatris —Hatfield
- Full-time
- Hybrid work
- Bachelor's degree
- Time management
- Health & wellbeing programme
- Employee assistance programme
SERM Scientific Director
GlaxoSmithKline —London
- Full-time
- Doctoral degree
- Bachelor's degree
- In-person
3d

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Regulatory Scientist

Orchard Therapeutics -
London

Quick apply

Job details

Full-time

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

pharmacovigilance jobs in london, eng

Regulatory Scientist

Drug Safety Associate II

Clinical Research Associate - Midlands

Medical Science Liaison - Neuroscience

Clinical Safety Coordinator

Content Writer - Pharmacovigilance

Director, Pharmacovigilance

Associate Consultant - R&D Advisory

Associate Consultant - R&D Advisory

Consultant - R&D Advisory

Consultant - R&D Advisory

12 month FTC- Spanish speaking Medical Information Specialist

Senior Manager, Patient Safety Scientist

Engagement Manager - R&D Advisory

Engagement Manager - R&D Advisory

Director, Development Unit CQA Program Lead

Pharmacy Dispensing Assistant

Associate - Inside Sales, PV Products

Director Safety Surveillance & Risk Management (12 months fix term contract)

SERM Scientific Director

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