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Job Details

Regulatory Affairs Executive

Company: Sandoz Biopharmaceuticals
Location: United Kingdom Frimley / Camberley
Reference: 237035BR
Closing Date: 24 Jun 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Regulatory Affairs Executive, Novartis, UKJob purpose: The performance of pre and post approval regulatory activities to ensure compliance whilst supporting business needs.Key Responsibilities:- Preparation and submission of the following:- MA variation and renewal applications- Change of ownership applications- MRP/DCP National Phases- Creation, assessment and approval of artwork texts and mock-ups.- Licence cancellations.- Sunset Clause monitoring and reporting. ...

Requirements:

Regulatory Affairs Executive, Novartis, UK


Job purpose:

The performance of pre and post approval regulatory activities to ensure compliance whilst supporting business needs.

Key Responsibilities:

- Preparation and submission of the following:
- MA variation and renewal applications
- Change of ownership applications
- MRP/DCP National Phases
- Creation, assessment and approval of artwork texts and mock-ups.
- Licence cancellations.
- Sunset Clause monitoring and reporting.
- Working in accordance with Global and local Working Instructions and SOPs.
- Maintenance of manufacturing, import and Wholesale Dealer’s licenses.
- Maintenance of regulatory archives.
- Reviewing and updating Summaries of Product Characteristics.
- The processing and clear communication of regulatory approvals to internal and external stakeholders.
- 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.


About Novartis:

Our mission is to care and cure; We want to discover, develop and successfully market innovative products to prevent and cure diseases, to ease suffering and to enhance the quality of life. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest their money, their time and their ideas in our company.

Novartis Pharmaceuticals UK has been certified by the Top Employers Institute as “Top Employer Europe 2017”!


Benefits of Working for Novartis:

Competitive Salary
Annual Bonus
Strong Work/Life Balance, flexible working
Top UK Employer
Pension Scheme
Share Scheme
Paid holidays
Comprehensive Medical Insurance
Subsidised Canteen
Employee Recognition Scheme
Sports & Social Club

‘I came for the job, I stay for the culture’

#LI-NOV

Minimum requirements

The ideal candidate will have:

Essential:
Experience in Regulatory Affairs within a Generic or Pharma business.
Ability to be flexible and multi-task within a fast paced environment.

Desirable:
Experience in working with CMC elements of a product dossier.
Experience in project management.
Experience of Competent Authority inspections.

Apply for this job: Regulatory Affairs Executive

Contact Information:

Address:  Head Office
Sandoz Biopharmaceuticals Mengeš Lek Pharmaceuticals d.d. Kolodvorska 27 1234 Mengeš SLOVENIA

Slovenia
Tel:  +386 (0)31 331 029
Website:  Visit Our Web Site

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