We have an exciting new opportunity within the Regulatory Affairs and Quality team for an experienced Senior Regulatory Affairs Executive.  The role will be reporting to the Regulatory Affairs and Quality Manager, and will have key accountabilities for maintaining the current Takeda UK and Ireland product portfolio and obtaining new regulatory approvals in the UK and Ireland in support of Takeda’s commercial activities and strategy.

The successful candidate will have a minimum of 4 years Regulatory Affairs experience and ideally have the related qualifications. They will be responsible for:

  • Maintenance of existing and new Marketing Authorisation’s in the UK and Ireland registered via national, MRP, DCP and Centralised procedures.
  •  Provision of support to Global Regulatory Affairs in relation to regulatory applications and strategy when required.
  • Ensuring appropriate communication with key stakeholders internally and externally, including with the Regulatory Authorities, negotiating where required to ensure a positive outcome for Takeda.
  • Maintaining familiarity with the Takeda UK and Ireland product ranges and keeping up to date with regulatory legislation and guidelines in the UK, Ireland and the EU.
  • Ensuring quality standards are consistently met and submissions are made according to the agreed deadline.

The ideal candidate will have experience of working with national, MRP, DCP and Centralised registrations, with a focus on post-marketing regulatory applications and product information.

The role offers excellent career progression to a candidate who is keen to drive continuous improvement and lead on change.

Further skills required for the role:

  • Excellent planning, time management and organisational skills
  • First class communication skills, both written and verbal
  • Knowledge of EU, UK and Ireland regulatory requirements
  • Strong influencing and negotiation skills with evidence of effective cross functional working
  • Driven and capable of delivering results efficiently and effectively
     

To apply please contact our HR consultant, Cally Howarth on 07880 500917 or send your CV to cally@halo-life.co.uk

 

 

Date of Preparation: May 2017

 

 

Takeda Pharma