Regulatory affairs manager Work, Jobs in Edgware, Gtl (with Salaries)

Regulatory Affairs Associate/Manager
Transpire BIO Inc. —London
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
Quick apply
Senior Regulatory Affairs Manager (UK/Ireland)
Perrigo —London
- Hybrid work
- In-person
- Leadership
Senior Manager Regulatory Affairs Lifecycle Management Medical Devices
Perrigo —London
- Hybrid work
- Bachelor's degree
- In-person
- Leadership
Exec Director, Regulatory Affairs
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
Regulatory Affairs Manager
Vodafone —London
- Full-time
- Analysis skills
- Leadership
- Communication skills
- Annual leave
Regulatory Affairs Manager
Reckitt —Slough
- Management
- Communication skills
- Employee assistance programme
- Life insurance
Quality and Regulatory Manager
Advanced Healthcare Technology Ltd —Waltham Cross
- £50,000 - £60,000 a year
- Full-time
- No degree
- Organisational skills
- In-person
- Free parking
Quick apply
Senior Manager Medical Information
Vertex Pharmaceuticals —Paddington
- Full-time
- Remote
- Analysis skills
- Bachelor's degree
- In-person
Head of Quality Assurance and Regulatory Affairs
Qureight Ltd —London
- Full-time
- Hybrid work
- Project management
- Bachelor's degree
- Machine learning
- Annual leave
- Life insurance
Quick apply
3d
Regulatory and Scientific Affairs Senior Manager | Leatherhead Food Research
Sagentia Regulatory —Epsom
- Full-time
- Management
- Mentoring
- Organisational skills
Quick apply
GB Sr. Manager, Regulatory Affairs - Europe
The Bountiful Company —London
- Bachelor's degree
- Leadership
- Communication skills
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
Single Sponsor Clinical Project Manager II (Virology) - 3 days a week in Uxbridge.
Syneos - Clinical and Corporate - Prod —London
- Full-time
- PMP
- Project management
- Bachelor's degree
Senior Manager/Associate Director, Government and Regulatory Affairs
Access Partnership —London
- Hybrid work
Quick apply
Account Manager (Public Affairs)
Hanbury Strategy —London
- Hybrid work
- Project management
- Mentoring
- Leadership
- Health & wellbeing programme
- Annual leave
Clinical Trials Manager
Gilead Sciences —London
- Full-time
- Management
- Doctoral degree
- Master's degree
Senior Regulatory Specialist
Androlabs —London
- £85,000 - £108,000 a year
- Full-time
- Hybrid work
- IT
- Annual leave
Quick apply
10d
Senior Director, Regulatory Affairs, EMEA
Ultragenyx Pharmaceutical —London
- Full-time
- Doctoral degree
- Master's degree
- Analysis skills
- Employee stock purchase plan
- Annual leave
6d
Manager - LIFE SCIENCES & HEALTHCARE – EU
Sia —London
- Full-time
- Doctoral degree
- Master's degree
- Business development
Quick apply
Regulatory Affairs Manager
pladis —Chiswick Park Station
- Full-time

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Regulatory Affairs Associate/Manager

Transpire BIO Inc.
London

Quick apply

Job details

Full-time

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Office
Analysis skills
Bachelor's degree
Product development
Organisational skills
Communication skills
Adobe Acrobat
FDA regulations
Time management

Full job description

Position Summary

The Regulatory Affairs Associate/Manager will support the regulatory team in ensuring adherence to all applicable regulations and guidelines related to inhalation pharmaceutical products development and the filing of marketing authorization applications such as ANDAs to the FDA, and MAAs to UK and EU Agencies. This role involves preparing regulatory documents, and marketing application filings, primarily at an operational level. The ideal candidate will be strongly detail oriented, ability to write Common Technical Documents (CTD) documents and have strong organizational skills.

This role is ideal for a candidate who has extensive technical CMC authoring experience in inhalation product development and wishes to transition to a role in regulatory affairs.

Essential Duties and Responsibilities

Document Preparation: Generate high quality marketing authorization applications (NDAs and ANDAs in the US and MAAs in the UK/EU) that meet regulatory guidance for the market. Ensure conformance to eCTD technical specifications, and study data technical conformance. Author CTD sections in Modules 1, Module 2 and Module 3 from technical documents. Maintain full awareness of all assigned regulatory activities and ensure that project deadlines and performance standards are met. Participate in deficiency review and response generation.

Regulatory Compliance: Ensure submissions meet local market requirements to avoid any Refuse-to-Receive (RTR), validation failures and deficiencies. Review includes a critical detailed assessment that technical documentation and information is available, accurate and complete for submission against relevant regulatory guidance’s from ICH, EMA, FDA, MHRA and other global health authorities.

Regulatory Strategy Support: Assist in the development and implementation of regulatory strategies for product development and approval.

Cross-Functional Collaboration: Work closely with other departments, including R&D, Quality Assurance, Clinical Development, Operations, and external vendors to gather necessary information for regulatory submissions. Represent regulatory affairs in project team meetings and provide regulatory guidance and perspective to team members in determining appropriate actions in order to meet scheduling timelines and/or in resolving technical issues.

Regulatory File Maintenance: Maintain and organize regulatory files and databases, ensuring all documents are up-to-date and easily accessible.

Regulatory Life Cycle Management: Prepare, compile, and submit post-approval documents including CMC changes, annual reports, variations, and license renewals ensuring all products maintain regulatory compliance to regulatory requirements. Evaluate change controls and formulate strategies for correct filing categories, with guidance from manager. Proactively raise major project issues if any to manager for resolution and agreement.

Required Qualifications

Education Requirements:

Bachelor's Degree: A bachelor's degree in a relevant field such as Life Sciences, Pharmacy, Chemistry, or a related discipline is required.

Work Experience Requirements:

5 years or more experience in inhalation drug delivery (pMDI, DPI, SMI) in technical CMC role or regulatory affairs (technical) role

Skills and Abilities

Ability to summarize complex technical documents into submission CTD documents that meet regulatory agency expectations.

Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects

Excellent organization and time management skills and ability to multi-task in a high-volume environment with shifting priorities

Excellent written and verbal communication skills and interpersonal skills.

Ability to communicate effectively and collaboratively as part of a team in a respectful manner.

Ability to work independently, self-starter.

Good problem-solving skills and analytical ability.

Ability to work with professionals domestically and abroad.

Specialized Knowledge

Working knowledge and experience with applicable regulations 21 CFR, US FDA guidelines, ICH guidelines, EMA guidelines and MHRA guidelines.

Technical working knowledge of inhalation dosage forms (pMDI, DPI, SMI).

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat Professional is a must.

Why Join Us?

We are a fast-growing pharmaceutical startup dedicated to innovation and improving patient outcomes. Join us to gain hands-on experience in a growing pharmaceutical business, get exposure to various functions with opportunities for career development and work in a collaborative and supportive work environment.

Quick apply

Refine Your Search

regulatory affairs manager jobs in edgware, gtl

Regulatory Affairs Associate/Manager

Senior Regulatory Affairs Manager (UK/Ireland)

Senior Manager Regulatory Affairs Lifecycle Management Medical Devices

Exec Director, Regulatory Affairs

Regulatory Affairs Manager

Regulatory Affairs Manager

Quality and Regulatory Manager

Senior Manager Medical Information

Head of Quality Assurance and Regulatory Affairs

Regulatory and Scientific Affairs Senior Manager | Leatherhead Food Research

GB Sr. Manager, Regulatory Affairs - Europe

Quality Assurance Officer

Single Sponsor Clinical Project Manager II (Virology) - 3 days a week in Uxbridge.

Senior Manager/Associate Director, Government and Regulatory Affairs

Account Manager (Public Affairs)

Clinical Trials Manager

Senior Regulatory Specialist

Senior Director, Regulatory Affairs, EMEA

Manager - LIFE SCIENCES & HEALTHCARE – EU

Regulatory Affairs Manager

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