Associate director, regulatory affairs Work, Jobs (with Salaries)

Associate Director, Regulatory Affairs - UK & Ireland
BeiGene —Remote
- £80,700 - £100,900 a year
- Full-time
- Remote
- Microsoft Powerpoint
- Management
- Bachelor's degree
Culture & Organisational Effectiveness Manager
Syensqo —Oldbury
- £125,000 - £171,000 a year
- Research
- Language training provided
Quick apply
Associate Director, Regulatory Affairs
WEP Clinical —Remote
- Full-time
- Hybrid work
- Management
- Computer literacy
- Microsoft Office
- Employee assistance programme
Regulatory Affairs Officer
Ipsen Ltd —London
- Full-time
- Hybrid work
- Databases
- Project management
- Continuous improvement
2d
Global Senior HRBP
Syensqo —Oldbury
- £82,000 - £103,000 a year
- Remote
- Master's degree
- Project management
- Bachelor's degree
Quick apply
9d
Senior Regulatory Affairs Specialist for UK and Ireland
Galderma —London
- Full-time
- English
- Project management
- Communication skills
2d
Associate Director of Public Health (NWJCC)
Cwm Taf Morgannwg University Health Board —Pontypridd
- £114,099 - £166,585 a year
- Full-time
- Leadership
Director, Corporate Affairs and Communications, UK & Ireland
BeiGene —Remote
- £105,700 - £132,100 a year
- Full-time
- Remote
- CRM software
- Doctoral degree
- English
Regulatory Affairs Strategist
Perrigo —London
- Hybrid work
- English
- Bachelor's degree
- In-person
9d
EU Regulatory Affairs Manager (Biosimilars)
Amgen —London
- £48,957 - £66,237 a year
- Remote
- Continuous improvement
- Conflict management
- Communication skills
- Work from home
12d
Associate Director Improvement and Personalisation
NHS Greater Manchester Integrated Care —Trafford
- £94,356 - £108,814 a year
- Full-time
- Leadership
2d
Global Regulatory Associate Director, Life Cycle Management
Novartis —London
- £67,900 - £126,100 a year
- Full-time
- Hybrid work
- Master's degree
- Bachelor's degree
- Continuous improvement
Director - Regulatory Affairs Lifecycle Management Medicines
Perrigo —London
- Hybrid work
- Bachelor's degree
- Continuous improvement
- Team management
1d
CMC Associate Director
Androlabs —London
- £85,000 - £108,000 a year
- Full-time
- Hybrid work
- Continuous improvement
- Budgeting
- Manufacturing
- Annual leave
Quick apply
Head of Global Student Recruitment & Associate Director of Global Engagement
University of Reading —Reading
- £59,966 - £67,468 a year
- Full-time
- Business development
- University
- Recruiting
Conduct and Regulatory Affairs Director
Allianz —London
- Full-time
- Hybrid work
- Writing skills
- Analysis skills
- Organisational skills
- Employee discount
10d
Associate Director, Global Medical Affairs (2-year contract)
BioNTech AG —London
- Full-time
- Doctoral degree
- Project management
- Travel
Associate Director, Global Inclusion & Community
Cambridge Associates LLC —London
- £68,600 - £89,200 a year
- Full-time
- Project management
- Bachelor's degree
- Communication skills
Associate Director of Strategic Procurement/Contracting
NHS Bristol, North Somerset and South Gloucestershire Integrated Care Board —Bristol
- £79,504 - £91,609 a year
- Full-time
5d
Associate Director of Campus and Commercial Services
University of Sheffield —Sheffield
- £80,524 - £111,391 a year
- Full-time
- Hospitality
- Management
- University
- Annual leave
- Employee discount

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Associate Director, Regulatory Affairs - UK & Ireland

BeiGene -
Remote

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Job details

Full-time
£80,700 - £100,900 a year

Qualifications

Microsoft Powerpoint
Management
Stakeholder collaboration
Labelling
Stakeholder liaison
Mentoring junior staff
Internal department liaison
Bachelor's degree
Risk management
Mentoring
Multidisciplinary collaboration
Pharmaceutical industry setting experience
Cross-functional collaboration
Cross-functional communication
Corporate regulatory compliance oversight

Full job description

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

The Associate Director of Regulatory Affairs will be responsible for developing and implementing UK regulatory strategies for development programs to secure and maintain the marketing authorization for product(s) in line with business objectives, and in coordination with key internal stakeholders. This will also include oversight and management of commercial products for both UK and Ireland.

Essential Functions of the job:

This individual will lead the UK RA team to manage regulatory aspects of designated compounds (NME/New indications) through all phases of development, registration, post-approval, and lifecycle of the product as detailed below:

Collaborate with key internal stakeholders to define UK MAA strategy and ensure the regulatory strategy is incorporated and implemented in line with product development objectives
Manage the content of and prepare regulatory (UK MAA) dossiers. Have knowledge of the content of the EU MAA dossiers to support labeling updates and management in Ireland ensuring compliance with UK and Ireland regulatory requirements. Oversee and be accountable for regulatory agency communications, submissions, and approvals, with a quality focus to secure first-cycle/attempt approvals
Review and provide input into promotional materials for both UK and Ireland
Act as the RA liaison within the UK Leadership team, attend regular meetings and provide input into UK business strategy
Prepare team for HA interactions, and moderate and lead discussions, be the main MHRA contact for strategic, non-study specific topics and provide support to the EU RA team for clinical matters related to Health Authority topics.
Proactively anticipate and mitigate regulatory risks while maintaining current knowledge of regulatory intelligence, procedures, changes, and trends.
Provide submission gap analyses, identify potential risks and propose potential solutions/mitigation plans to ensure successful acceptance of submissions.
Ensure compliance with EU/UK global regulatory requirements.

To lead and mentor junior team members.
Represent BeOne at UK industrial association meetings and congresses

Supervisory Responsibilities:

Junior Regulatory Affairs professionals

Computer Skills: Extensive experience with Microsoft Office suite, Veeva regulatory publishing and expertise with PowerPoint presentation authoring and presentation.

Education Required:

Bachelor’s degree required; advanced degree preferred.

Other Qualifications:

Minimum of 8 years’ experience in the biotechnical or pharmaceutical industry, and a minimum of 8 years’ experience in a Regulatory capacity with a broad background.
Experience working with MHRA regulatory procedures is mandatory for this role.
Sound understanding of the drug development process, the pharmaceutical industry and healthcare environment including UK regulatory requirements and policy trends
Recent experience with oncology products and MAAs, ODD, PIP is preferred
Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

Location: UK, fully remote

Travel: Travel to internal meetings in UK monthly or bimonthly. Additional travel to EU locations occasionally

Salary Range UK: 80,700.00 GBP - 100,900.00 GBP

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

Fosters Teamwork
Provides and Solicits Honest and Actionable Feedback
Self-Awareness
Acts Inclusively
Demonstrates Initiative
Entrepreneurial Mindset
Continuous Learning
Embraces Change
Results-Oriented
Analytical Thinking/Data Analysis
Financial Excellence
Communicates with Clarity

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Apply Now

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