Senior Regulatory Affairs Officer

You will be working in close collaboration with Manufacturing sites, Corporate Regulatory Affairs, EURMEA Regulatory Affairs, Marketing Managers and Medical Safety, the Senior Regulatory Affairs Officer will prepare and submit high quality and timely regulatory applications to the MHRA/IMB, coordinate activities with Regulatory Affairs Officers and act as key UK/Ireland contact within regional regulatory organisation. Following licence submission, the Senior Regulatory Affairs Officer will be in regular contact with the MHRA/IMB, responding to questions and ensuring progress leading to a successful conclusion.  Your Areas of Responsibility will include:

• Work autonomously in the compilation and submission of Clinical Trial Applications, Varia-tions, Renewals, Product Information changes and responses to Requests for Further Infor-mation, within specified timelines and to agreed quality standards.

• Participate in the preparation of registration dossiers and project manage local Marketing Authrorisation Applications as well as other regulatory initiatives.

• Pursue maintenance activities for assigned portfolio to ensure ongoing compliance with local and EU regulations and company procedures.

• Be fully aware and up to date on all ongoing activities and documents within allocated port-folio/projects  and routinely advise the Head of Regulatory Affairs, and other company stakeholders, as to their status.

• In-depth (scientific and technical) product knowledge to facilitate discussions at a senior level.

• Analyze data to extract decision-making information and take/recommend appropriate courses of action.

• Keep abreast of local legislation and guidelines and provide regular updates to local colleagues.

• Advising colleagues from Corporate Regulatory Affairs, EURMEA Regulatory Affairs and the manufacturing sites on local regulatory requirements as required.

• Develop good working contacts with personnel at the Health Authorities.

• Written and oral communications with MHRA, IMB and other regulatory authorities; review critical communications with Head of Regulatory Affairs before implementation.

• Regular participation and country representation at Global regulatory meetings.

• Liaise on new product registration strategies and activities with Head of Regulatory Affairs, EURMEA Regulatory Affairs and Corporate Regulatory Affairs.

• Review promotional sales material to ensure compliance with registered product licence particulars and applicable promotional codes of practice.

• Creation and maintenance of local Standard Operating Procedures (SOP’s) covering areas of responsibility.

• Perform such other duties as may reasonably be required

Key Performance Indicators 

• Education (Minimum): Life sciences degree (2:2 or above)
• At least 3 years experience in regulatory affairs/related discipline
• Ability to achieve deadlines on multiple projects
• Ability to work autonomously with minimal supervision
• Analytical, and with good communication skills
• Knowledge of regulatory requirements and guidelines for drugs and devices

Even if you are unsure on your suitability for this position but you are looking at the possibility of some progression in your current job or a change in your career path, please feel free to contact me for a friendly chat to explore any options that may be open to you.

All enquiries will be dealt with in a strictly confidential manner.Call Matt on 01293 776644 or email me at mhart@barringtonjames.com