Regulatory Affairs - Senior Regulatory Affairs Officer Job in Surrey
Competitive salary and extensive benefits
Flame Pharma has been assigned to recruit a new team of regulatory professionals for a top 5 pharma company in Surrey. We are recruiting a Senior Regulatory Affairs Officer to 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 license 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
Key aspects of the post
- Work autonomously in the compilation and submission of Clinical Trial Applications, Variations, Renewals, Product Information changes and responses to requests for Further Information, within specified timelines and to agreed quality standards
- Participate in the preparation of registration dossiers and project manage local Marketing Authorisation 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 portfolio/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 license particulars and applicable promotional codes of practice
- Creation and maintenance of local Standard Operating Procedures (SOP’s) covering areas of responsibility
- Assist in coaching and developing and provide day to day direction to less experienced members of the team
- Deputise for the Head of Regulatory Affairs as required
Key requirements of the post holder
- BSc (essential)
- Proven regulatory experience within pharma or devices (must have experience within the UK market)
- 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
To apply for this Job or enquire about additional Regulatory Affairs Officer Job Opportunities across the UK and Europe - Contact Flame Pharma free phone on 0800 085 0858 or calling from a mobile on 0115 8114488 or email careers@flamepharma.com
Flame Health Associates LLP incorporating Flame Pharma operates as an Employment Agency & Employment Business
Key Words Pharmaceutical, Regulatory Affairs, Senior Regulatory Affairs Officer, Surrey