2 roles: Head of Regulatory Affairs and Regulatory Affairs Officer
Salary: £50,000 – £75,000, plus car allowance, bonus & package
Location: Surrey or Essex
Our client is seeking a Head of Regulatory Affairs who wants to lead a Regulatory Affairs department in a growing international business. You will be responsible for and managing the UK Regulatory Affairs budget in this £400m global business. This opportunity will suit a results-driven person who can lead teams and develop people. Perhaps you are a manager in a similar organisation and are ready to step into a Head of role for the first time.
Please note, there is a Regulatory Affairs Officer role as well as the Head of role.
You will have the autonomy to engage with external stakeholders and regulators to gain competitive intelligence and plan and prepare high quality regulatory submissions to authorities within agreed timeframes. You will also be interacting with government agencies including MHRA, Department of Health, and the Home Office.
Some of the duties you will have the opportunity to be involved with are:
- Develop and implement local UK registration strategies;
- Assist the Head of Scientific Affairs in strategy development for efficient running of the department;
- Ensure market authorities are updated in-line with new safety information;
- Highlight compliance issues with all products within the portfolio and make proposals for their resolution;
- Consider potential obstacles to approval of regulatory submissions, and actively problem solve;
- Monitor submissions and prepare any responses as required for deficiencies noted by authorities.
Within this PE-backed business you will be a hub of advice and expertise for the commercial team, and also working alongside the teams in Global Regulatory Affairs, supply chain, Medical Affairs, and the manufacturing sites.
For this role you will have:
- A recognised degree in science;
- Proven experience in achieving regulatory approvals in the UK;
- 5-8 years in a management role (looking for your first Head of Role);
- Knowledge of development process for generic medicines, being capable of critically reviewing and integrating scientific information from a variety of disciplines.