Senior business development manager Work, Jobs in Hook, Ham (with Salaries)

Regulatory CMC strategy manager
ICON Plc —Reading
- Full-time
- Bachelor's degree
- Annual leave
- Employee assistance programme
Senior Product Owner
cinch —Hook
- £65,000 - £72,000 a year
- Monday to Friday
- Hybrid work
- Communication skills
- Negotiation
- Employee assistance programme
Quick apply
1d
Senior Business Development Manager
Wireless Logic mdex GmbH —Reading
- Hybrid work
- Sales
- Business development
- Communication skills
Defence Business Development Manager
Venta Global —Hook
- Full-time
- Business development
- Travel
- Negotiation
- Employee discount
Quick apply
Placement Manager
The OT Practice —Hook
- £35,000 - £40,000 a year
- Full-time
- Hybrid work
- Sales
- Project management
- Organisational skills
- Free parking
Quick apply
Regional Operations Director - Places Leisure
Places for People —Camberley
- £80,000 - £90,000 a year
- Contracts
- Leadership
- Annual leave
- Employee discount
Senior Account Manager, Client Services - Rugby (Event Branding and Signage)
Wasserman Media Group LLC —Hook
- Weekend availability
- Project management
- Organisational skills
- Communication skills
Senior Business Development Manager
Sage —Winnersh
- Hybrid work
- Sales
- Business development
- Bachelor's degree
Senior Defence Business Development Manager - Europe
Collins Aerospace —Wokingham
- Full-time
- Sales
- Business development
- Project management
- Annual leave
- Employee assistance programme
1d
Senior Commercial Manager, UK Beverages
PepsiCo —Reading
Senior Regulatory Affairs Manager
Elanco —Hook
- Full-time
- English
- Master's degree
- Leadership
CX Team Leader (Fixed-Term-Contract)
cinch —Hook
- Up to £35,000 a year
- Monday to Friday
- Sales
- Customer service
- Financial services
- Employee assistance programme
Quick apply
7d
Senior Commercial Manager – Launchpad
BAE Systems —Frimley
- £75,000 a year
- University
- Travel
- Contracts
14d
Senior M365 Platform Engineer
BCA —Hook
- Up to £52,000 a year
- Monday to Friday
- Hybrid work
- Analysis skills
- Mentoring
- SharePoint
- Employee assistance programme
- Employee discount
Quick apply
14d
Health & Safety Manager – Luxury Estate & Hospitality Operations
Splendid Works —Windsor
- £40,000 - £60,000 a year
- Full-time
- Hospitality
- Management
- English
Quick apply
7d
Business Development Manager (Defence)
Fujitsu —Basingstoke
- Full-time
- Business development
- Travel
- Contracts
- Annual leave
- Employee assistance programme
14d
Key Account Manager
Loma Systems —Farnborough
- £60,000 - £75,000 a year
- Full-time
- Microsoft Powerpoint
- Sales
- Salesforce
- Health & wellbeing programme
- Work from home
Quick apply
Senior Account Manager
Marketbridge —Marlow
- £42,000 - £50,000 a year
- Full-time
- Hybrid work
Senior SHE Manager
Brush Group —Hook
- Monday to Friday
- Hybrid work
- Microsoft Office
- Continuous improvement
- Leadership
- Employee assistance programme
- Life insurance
General Manager – 5* Luxury Hotel (New Opening)
Splendid Works —Windsor
- £70,000 - £85,000 a year
- Full-time
- Hospitality
- English
- Hotel
- Free parking
- Sick pay
Quick apply
7d

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Regulatory CMC strategy manager

ICON Plc -
Reading

Apply Now

Job details

Full-time

Benefits

Annual leave
Discounted gym membership
Employee assistance programme
Free or subsidised travel
Childcare

Qualifications

Bachelor's degree

Full job description

Senior regulatory affairs CMC manager

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

As a Senior Manager, Regulatory Strategy (CMC strategy) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are seeking a highly motivated and qualified regulatory CMC professional for the Global Regulatory Affairs team at ICON this is a fixed term contract initially until 31st March 2027.
The Senior Manager, CMC Strategy is responsible for global CMC regulatory strategies and activities for a large Pharma portfolio through clinical development, market launch and product lifecycle management.

The successful candidate will provide an effective and aligned regulatory CMC strategy and submission approach globally, regionally and locally.

What you will be doing:

Defining, coordinating and implementing global CMC regulatory strategies for product specific development and life-cycle activities
Providing proactive strategic guidance to the product-specific global regulatory and
manufacturing sub-teams for defining global regulatory CMC strategies and objectives
pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets.
The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters.
Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval.
Manages the CMC regulatory strategy of high quality and compliant regulatory CMC
documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives.
Advises on regulatory strategies, solutions to scientific problems and interpretation of
results in the context of product registration requirements combined with the business
need and goals.
Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.
Identifies and recommends the most effective CMC regulatory strategies to assure a
first-pass regulatory approval of initial application and lifecycle supplements/variations.
Product registrations in global markets.
Provides proactive guidance and regulatory strategies to support product teams.
Interfaces with key functions in the preparation, review and
approval of regulatory CMC submissions as assigned to product and programs.
In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk
management solutions in consultation with cross-functional teams.

Your Profile:

You will have solid regulatory affairs experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

Bachelor's degree in a relevant scientific discipline or healthcare-related field
The role requires an extensive experience in global pharmaceutical/biotechnological drug
development and proven knowledge of the global regulatory CMC environment.
Demonstrated experience in authoring and managing components of regulatory submissions
Good knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA. Ability to support regional and local regulatory affairs teams for Interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health
Canada, etc.).
- Demonstrated ability to develop and implement global CMC regulatory strategies, resolve
complex issues, and negotiate optimal regulatory pathways and outcomes with health
authorities.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Apply Now

Refine Your Search

senior business development manager jobs in hook, ham

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