|Job type||Full Time|
At LEO Pharma , we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today.
Every day, we seek inspiration from people living with skin diseases. We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives.
As a purpose-driven company, high performance is measured equally as sales results and the positive impact we create - for health care professionals and their patients. These aspirations are encapsulated in our perpetual quest for the world's best talent.
As Principal Regulatory Affairs Executive you will have responsibility to positively contribute towards increasing the company's financial results and the appropriate use of LEO Pharma products
As Principal Regulatory Affairs Executive you will be responsible for obtaining and maintaining clinical and/or marketing authorization approval for the company's products; providing strategic regulatory input from local market to drug development; secure essential interface with EU Regional Leads; maintaining strong and positive working relationships with the Health Authorities in the UK and Ireland, Global Regulatory Affairs (GRA) and other key Global Departments.
• Responsible for executing highly complex or specialised projects or activities essential to the achievement of overall functional objectives.
• Input into the preparation of applications to the UK Health Authority, the Medicines and Healthcare products Regulatory Agency (MHRA) and the Irish Health Authority, the Irish Healthcare Products Regulatory Authority (HPRA), for Clinical Trial and Marketing Authorisation approval.
• Maintenance of existing Clinical Trial and Marketing Authorisations.
• Preparation and maintenance of text for product packaging, patient leaflets, SmPCs, etc.
• Update and verify eRIMS records, as applicable, for products registered in the UK and IE.
• Creation of local regulatory documents as applicable.
• Regulatory check of company promotional material to ensure consistency with the Marketing Authorisation.
• Uploading and circulating regulatory documents in the electronic system, as applicable.
• Maintain current awareness of legislation affecting pharmaceuticals in UK, IE and Europe.
• Maintain good working relationships with the Regulatory Authorities (MHRA, HPRA, EMA) and trade associations.
• Maintain good working relationships with personnel in GRA to ensure all necessary data for submissions are available in a timely manner.
• Deputise for the Head of Regulatory Affairs, or other team members, on an ad hoc basis, including representing UK/IE RA at global and external meetings.
• Effectively communicate, both internally and externally, to key stakeholders, on matters of varying complexity.
• Contact with Regulatory Authorities, Trade Associations and other pharmaceutical companies, including attendance at external meetings. Reading of journals and other published articles.
• Review of new legislation when issued, and sharing information with key stakeholders, as applicable.
• RA Project Management, with minimal supervision.
• Active participation in RA Working Groups.
• Coaching and mentoring of other GRA team members.
• Development of proposals to enhance existing processes and practices.
• Good Distribution Practice (GDP) deputy, in the absence of the Head of Regulatory Affairs.
• Support for the Annual Product Quality Review (APQR) for relevant product responsibilities.
• Attendance at overseas meetings, including Head Office and other EU+ affiliates, as required.
• Degree in Life Sciences or Pharmacy or equivalent experience.
• Experience with Good Distribution Practice (GDP)
• A high level of experience within Regulatory Affairs is essential for this role, as is knowledge and understanding of the pharmaceutical industry, particularly the Medical, Commercial, Market Access, Research and Information functions.
• Ideally familiar with MHRA Portal and CESP, electronic document and information management systems (eg Veeva, eRIMS, eDOC and MyDoc) and IT systems (eg MS Word, Excel, Powerpoint, Lotus Notes, Visio and Outlook).
• Take ownership and accountability of results.
• Manage complexity
• A clear and confident communicator, comfortable dealing with and influencing both peers and leaders within the business
• Clear ability to bring people from different teams together and work cross functionally
• Being resilient
Please note that we review applications and conduct interviews on an ongoing basis.