Regulatory Affairs Specialist

Square One Resources Limited
Hemel Hempstead
£45,000 - £55,000
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Square One Pharma is recruiting on behalf of there UK based client.The selected candidate will be responsible forthe following:

- Planning, preparation and submission of MA applications, variations, renewal documents, post marketing commitment submissions and other ad hoc activities in support of maintaining MAs in MENA, Africa, UK and possibly other RoW territories.

- Reviewing and submitting artwork and labelling changes.

- Managing external pharmacovigilance and medical information agent

- Working alongside external regulatory consultants

- Building and maintaining effective relationships with external clients/partners alongside partner's regulatory teams

- Managing/supporting a range of changing project demands

- Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions

- Developing and maintaining strong working knowledge of regulatory guidelines

- Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business.

- Responsibility for ensuring that all relevant electronic systems are updated and maintained in alignment with regulatory submissions and commitments.

- Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).

Skills & Experience Required:

- Experience in regulatory affairs

- In-depth working knowledge of MHRA, EMA regulations, and MENA regulations

- Ability to multitask and manage multiple deadlines

- Capacity to react quickly and decisively in unexpected situations

- Excellent verbal and written communication skills

- Self-motivated with the ability to work well autonomously

- Flexibility and ability to think outside the box

- Experience working with government agencies and trade organisations to clarify and resolve regulatory matters.

- Minimum 4-5 years' regulatory experience