Affairs executive Work, Jobs in Fleet, Eng (with Salaries)

Regulatory Affairs Executive
Sandoz —Bracknell
- Full-time
- Project management
- Agile
- Annual leave
Science Estates Support Officer
Animal and Plant Health Agency —New Haw
- £33,350 - £34,435 a year
- Overtime
- Microsoft Powerpoint
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Research Scientist - Equine Virology (ID4569)
Animal and Plant Health Agency —New Haw
- £38,795 - £41,375 a year
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Associate Director, Regulatory Project Manager
CSL Behring —Maidenhead
- £170,000 - £210,000 a year
- Full-time
- Doctoral degree
- PMP
- Master's degree
4d
Research Scientist - Mammalian Virology (ID4471)
Animal and Plant Health Agency —New Haw
- £38,795 a year
- Overtime
- Presentation skills
- Bachelor's degree
- Communication skills
- Annual leave
- Employee discount
Marketing Executive
Zentiva Group, a.s. —Guildford
- Full-time
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- Project management
Virology Quality Manager (ID4629)
Animal and Plant Health Agency —New Haw
- £38,795 - £41,375 a year
- Overtime
- Computer literacy
- Microsoft Office
- Presentation skills
- Annual leave
- Employee discount
Associate Director, Internal Communications and Engagement
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Travel
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Regulatory Compliance Supervisor (m/f/x)
3M —Bracknell
- Full-time
- Management
- Engineering
- Master's degree
- Flexible schedule
Event Manager | High Wycombe (United Kingdom) | Full Time (40 Hours) | Permanent
The Church of Jesus Christ of Latter-day Saints —High Wycombe
- Weekend availability
- English
- Hotel
- Project management
Head, PV and Regulatory QA
CSL Seqirus —Maidenhead
- Full-time
- Customer service
- Bachelor's degree
- Organisational skills
Data Privacy Senior Executive
BDO —Reading
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- AI
4d
Senior Product Manager – Global Web
Elanco —Hook
- Full-time
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Director, International Commercial and Pandemic Communications
CSL Seqirus —Maidenhead
- Full-time
- Hybrid work
- Social media management
- Bachelor's degree
- Travel
Executive Director, Worldwide Operations Office - Pharmacovigilance
Regeneron —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
- Annual leave
Head of Global Regulatory Affairs
Karo Healthcare —Maidenhead
- Full-time
- Hybrid work
- Business
- Leadership
- Flexible schedule
Quick apply
International Account Manager & Business Development Executive
TensCare Ltd —Epsom
- £32,000 - £37,500 a year
- Full-time
- Hybrid work
- Sales
- English
- Microsoft Office
- Free parking
- Work from home
Quick apply
Enterprise Account Executive (Europe)
MasterControl —Basingstoke
- English
- Travel
- Computer skills
3d
Executive Director, Global Patient Safety Sciences Delivery
Regeneron —Uxbridge
- Management
- Doctoral degree
- Master's degree
- Annual leave
Regulatory Program Management - Sponsor Dedicated
IQVIA —Reading
- Azure
- PMP
- Project management
10d

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Regulatory Affairs Executive

Sandoz -
Bracknell

Apply Now

Job details

Full-time

Benefits

Annual leave
Company pension

Qualifications

Project management
Agile

Full job description

The performance of various regulatory activities to ensure timely, accurate and strategic preparation and submission of registration dossiers to obtain and launch new UK Marketing Authorisations whilst also supporting business needs such as re-introductions and portfolio expansion projects.

Your Key Responsibilities:Your responsibilities include, but not limited to:

The execution of business aligned regulatory filing strategies in collaboration with regional and local stakeholders to meet the product launch deadline.
Preparation and submission of the following New Marketing authorisation application (National/DCP/MRP/CP), MA variation, Change of ownership applications and Educational materials and associated risk minimisation measures
Timely execution of launch enabling regulatory activities such as the registration of Risk Management Plans and associated educational materials, the registration and sign off artworks, approval of launch limiting variations.
Engagement with the MHRA to address application queries, liaising with relevant company departments and external sources to ensure full and rapid responses.
Creation, assessment and approval of artwork texts and mock-ups.
License cancellations.
Sunset Clause monitoring and reporting.
Liaising with customers and third-party suppliers concerning regulatory activities such as own label supplier registration, ongoing maintenance, and change of ownerships, to ensure compliance is maintained whilst meeting customer expectations.
Liaising with launch team to input the progress of regulatory application and/ or projects to assist with mapping out product launch activities.
Handling the regulatory activities in relation to the re-introduction of license and coordination with other stakeholder to ensure execution of regulatory strategy in this regard.
Handling labelling changes and associated regulatory applications (e.g. PIQ) as per business or external needs.
Ensuring timely response to Corrective and Preventative Actions (CAPAs) assigned to DRA and other associated quality management activities.
Working in accordance with Global and local Working Instructions, SOPs whilst adhere to compliance.
Maintenance of regulatory archives and record keeping.
Reviewing and updating Summaries of Product Characteristics.
The processing and clear communication of regulatory approvals to internal and external stakeholders within set timelines.
Provision of regulatory support for medical information and patient safety to assist with queries on product information.
Provision of regulatory support for strategic commercial opportunities.
Provision of regulatory support for internal and external audits.
Carrying out other activities which contribute to the effective performance of the Regulatory Affairs Department.

What you’ll bring to the role:Essential Requirements:
Experience (2 to 3 years) in Regulatory Affairs within a Generic or Pharma business.
Experience in supporting new product launch activities.
Ability to be flexible and multi-task within a fast-paced environment.

Desirable Requirements:
Experience in working with new product registration& CMC elements of a dossier.
Experience in project management.
Experience in working with various variation applications.

You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.

Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported! 
 
Join us, help us make healthcare fairer and faster.

Commitment to Diversity& Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

Apply Now

Refine Your Search

affairs executive jobs in fleet, eng

Regulatory Affairs Executive

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Research Scientist - Equine Virology (ID4569)

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Research Scientist - Mammalian Virology (ID4471)

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Enterprise Account Executive (Europe)

Executive Director, Global Patient Safety Sciences Delivery

Regulatory Program Management - Sponsor Dedicated

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