Regulatory affairs Work, Jobs in Earley, Brk (with Salaries)

Regulatory Affairs Executive
Sandoz —Bracknell
- Full-time
- Project management
- Agile
- Annual leave
Sr. Regulatory Affairs Officer
Milpharm Ltd —Uxbridge
- £30,000 - £38,000 a year
- Full-time
- Maintenance
- Master's degree
- Bachelor's degree
- Life insurance
Quick apply
7d
Medical Writer - 6 Month Fixed Term Contract
BD —Winnersh
- £43,300 - £66,025 a year
- English
- Master's degree
- Presentation skills
Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA
Eli Lilly —Bracknell
- Full-time
- Doctoral degree
- English
- Master's degree
5d
Exec Director, Regulatory Affairs
Gilead Sciences —Uxbridge
- Full-time
- Hybrid work
- Management
- Doctoral degree
- English
Senior Benefits Risk Management Lead
Bayer —Reading
- £110,000 - £130,000 a year
- Full-time
- Hybrid work
- English
- Leadership
- Communication skills
- Annual leave
- Employee discount
Senior Regulatory Affairs Manager
Elanco —Hook
- Full-time
- English
- Master's degree
- Leadership
Regulatory Compliance Supervisor (m/f/x)
3M —Bracknell
- Full-time
- Management
- Engineering
- Master's degree
- Flexible schedule
Head of Global Regulatory Affairs
Karo Healthcare —Maidenhead
- Full-time
- Hybrid work
- Business
- Leadership
- Flexible schedule
Quick apply
Quality Assurance Regulatory Affairs Coordinator
Perspectum —Oxford
- £30,000 - £40,000 a year
- Full-time
- Microsoft Office
- IT
Quick apply
Team Leader - Regulatory Operations
Veterinary Medicines Directorate —New Haw
- £62,000 a year
- Part-time
- Management
- Microsoft Office
- Presentation skills
- Free parking
- Annual leave
2d
Regulatory Affairs Manager
Reckitt —Slough
- Management
- Communication skills
- Employee assistance programme
- Life insurance
Vice President, Regulatory Affairs – ELMAC
Amgen —Uxbridge
- Doctoral degree
- Master's degree
- Bachelor's degree
Senior Regulatory Associate
Pfizer —Walton-on-Thames
- Full-time
- Doctoral degree
- Marketing
- Computer literacy
1d
Director, Digitized Case Processing & Device Vigilance
Bristol-Myers Squibb —Uxbridge
- Full-time
- Hybrid work
- Oracle
- Management
- Doctoral degree
Regional Ethics and Compliance Officer - International
CSL Seqirus —Maidenhead
- Full-time
- Bachelor's degree
- Travel
- Business
Head of Application Management
Veterinary Medicines Directorate —New Haw
- £62,000 a year
- Part-time
- Management
- Microsoft Office
- Presentation skills
- Free parking
- Annual leave
2d
Head of Spectrum & Regulatory Affairs
Open Cosmos —Didcot
- Hybrid work
- English
PV Officer, Team Lead (Japanese Fluency required )
PrimeVigilance —Guildford
- Full-time
- Remote
- Nursing
- English
- Communication skills
Quick apply
Head of Global Labelling
CSL Seqirus —Maidenhead
- Full-time
- Leadership

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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

regulatory affairs jobs in earley, brk

Regulatory Affairs Executive

Sr. Regulatory Affairs Officer

Medical Writer - 6 Month Fixed Term Contract

Sr. Principal Scientist, Advisor, Sr. Advisor of Global Regulatory Affairs Chemistry, Manufacturing & Controls and Devices-EMEA

Exec Director, Regulatory Affairs

Senior Benefits Risk Management Lead

Senior Regulatory Affairs Manager

Regulatory Compliance Supervisor (m/f/x)

Head of Global Regulatory Affairs

Quality Assurance Regulatory Affairs Coordinator

Team Leader - Regulatory Operations

Regulatory Affairs Manager

Vice President, Regulatory Affairs – ELMAC

Senior Regulatory Associate

Director, Digitized Case Processing & Device Vigilance

Regional Ethics and Compliance Officer - International

Head of Application Management

Head of Spectrum & Regulatory Affairs

PV Officer, Team Lead (Japanese Fluency required )

Head of Global Labelling

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