Regulatory cmc Work, Jobs in London, Eng (with Salaries)

Regulatory Scientist
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Writing skills
- Bachelor's degree
- Computer skills
Quick apply
Global Change Facilitator – Regulatory CMC
BioPhorum —London
- Full-time
- Continuous improvement
- No degree
- Organisational skills
Quick apply
Associate Director, CMC Regulatory Affairs, International
Moderna, Inc. —London
- Full-time
- Engineering
- Master's degree
- Bachelor's degree
- Annual leave
CMC Associate Director
Androlabs —London
- £85,000 - £108,000 a year
- Full-time
- Hybrid work
- Continuous improvement
- Budgeting
- Manufacturing
- Annual leave
Quick apply
Associate Director, CMC Regulatory Science, International
Moderna, Inc. —London
- Full-time
- Doctoral degree
- Master's degree
- Annual leave
RA/CMC Specialist
Siemens Healthineers —London
- Full-time
- Hybrid work
- Communication skills
- Time management
- Employee assistance programme
Associate Director, Global Regulatory Science, CMC
Moderna, Inc. —London
- Full-time
- Engineering
- Master's degree
- Bachelor's degree
- Annual leave
DT Lead, Single Systems - CMC Development Sciences (UK)
UCB —Slough
- Computer Science
- Engineering
- English
Regulatory Strategy Director, Renal
Vertex Pharmaceuticals —Paddington
- Full-time
- Writing skills
- Bachelor's degree
- Continuous improvement
Sr. Field Application Scientist - Biology
Revvity —Seer Green
- Remote
- Doctoral degree
- Engineering
- Master's degree
Director - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
Compliance Advisory Officer
CMC Markets —London
- Full-time
- Research
- Analysis skills
- Team management
Senior Director, Early Phase CMC Medicine Research Leader
GlaxoSmithKline —Ware
- £202,125 - £336,875 a year
- Full-time
- Doctoral degree
- Travel
- Leadership
- Annual leave
1d
Global Product Operations Leader – Therapeutic Dermatology
Galderma —London
- Full-time
- Engineering
- English
- Master's degree
Business Analyst - Onboarding
CMC Markets —London
- Full-time
- Mentoring
- Agile
- SDLC
Senior Scientist - ELN & Data Specialist, Global Technical Development
Orchard Therapeutics —London
- Full-time
- Hybrid work
- Laboratory experience
- Bachelor's degree
- Continuous improvement
Quick apply
Head of Early Development Asset Operations
Ipsen Biopharm Ltd —London
- Full-time
- Microsoft Powerpoint
- Doctoral degree
- English
Compliance Officer
CMC Markets —London
- Full-time
- Microsoft Powerpoint
- Organisational skills
- Communication skills
Senior Scientist I - Metabolite Identification (AMS)
Pharmaron —Hoddesdon
- Doctoral degree
- Master's degree
- Bachelor's degree
Senior Director, Global Medical Expert - Gene Therapies
Ultragenyx Pharmaceutical —London
- Full-time
- Doctoral degree
- Travel
- Patient care
- Employee stock purchase plan
- Annual leave

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Regulatory Scientist

Orchard Therapeutics -
London

Quick apply

Job details

Full-time

Qualifications

Writing skills
Bachelor's degree
Computer skills
Multidisciplinary collaboration
Cross-functional collaboration

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 cmc jobs in london, eng

Regulatory Scientist

Global Change Facilitator – Regulatory CMC

Associate Director, CMC Regulatory Affairs, International

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Associate Director, CMC Regulatory Science, International

RA/CMC Specialist

Associate Director, Global Regulatory Science, CMC

DT Lead, Single Systems - CMC Development Sciences (UK)

Regulatory Strategy Director, Renal

Sr. Field Application Scientist - Biology

Director - Regulatory Affairs Lifecycle Management Medicines

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Senior Director, Early Phase CMC Medicine Research Leader

Global Product Operations Leader – Therapeutic Dermatology

Business Analyst - Onboarding

Senior Scientist - ELN & Data Specialist, Global Technical Development

Head of Early Development Asset Operations

Compliance Officer

Senior Scientist I - Metabolite Identification (AMS)

Senior Director, Global Medical Expert - Gene Therapies

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