Greater London, England, United Kingdom
Throughout my tenure, as a highly skilled and experienced Regulatory Operations Specialist, I have managed various regulatory systems, ensuring compliance with external requirements. My responsibilities have encompassed a wide range of tasks, including maintaining up-to-date regulatory knowledge, managing projects, and working closely with cross-functional teams to achieve common goals. My primary career objective is to further develop my expertise in core regulatory affairs. To achieve this goal, I am actively seeking opportunities that will enable me to expand my knowledge, skills, and experience in this area.
I have gained extensive experience in managing regulatory systems and ensuring compliance with external requirements. My primary responsibilities include: - Compliance of Quality Management Systems such as TrackWise. - Familiarising myself with all actions required to manage systems, such as eCTD life cycle maintenance activities through eCTD publishing and QMS progression. This includes profile maintenance via Samarind (eCTD maintenance and Publishing software). - Responding to eCTD publishing requests in a timely and compliant manner. - Developing Regulatory Operations Processes by creating Standard Operating Procedures (SOP), Work Instructions (WI), and Best Practice Guidelines (BPG) to ensure alignment with current ways of working as well as providing workshops to the wider regulatory community enabling compliance with external regulations. - Addressing questions from Samarind Users in relation to system usage, data, and maintenance, as well as eCTD submissions. - Maintaining processes that enable centralised publishing for the Central Team and Local Teams as required. - Familiarise with SPOR-OMS requirements and update information in SPOR-OMS where applicable. Career Progression, Recognition and Awards - CSCI RA Excellence Awards for Integrity in 2024. - Recognized for significant contributions to the Regulatory Community of Practice (rCOP) in 2023 and 2024 (multiple nominations). - Successfully managed responsibilities in Central publishing work concurrently, demonstrating strong multitasking abilities without direct support from a Regulatory Operations Lead. - Promoted from Regulatory Affairs Administrator to Regulatory Operations Associate, reflecting growth in expertise and responsibility within the regulatory field.
UK and Ireland Senior Consumer Service Advisor & Consumer Service Advisor, dealing with General Inquiries, Medical Inquiries, Adverse Event Reports and Product Quality Complaints. Being the first point of contact for consumers. These Medical reports and inquiries are received from patients/consumers on various platforms, such as E-Mail, Social Media Platforms, Phone Calls, Mails, External Partners and the MHRA. Adverse Events, Product Quality Complaints Inquiries processed to the companies data base and forwarded onto Global Patient Safety and Quality Teams. Promoted to Senior Consumer Service Advisor (September 2021). My primary responsibilities include: - Managing the UKLO Consumer Services inbox, identifying relevant functions within Perrigo responsible for actioning emails, and monitoring compliance and adherence to stipulated timelines for case logging in TrackWise. - Perform reconciliations with partners and reviewing Non-conformance (NC) reports. - Write and/or perform review of local procedural documents. - Monitoring trends of Product Quality Complaints. - Dealing with General Inquiries, Medical Inquiries, Adverse Event Reports, and Product Quality Complaints as the first point of contact for consumers. - Receiving Medical reports and inquiries from patients/consumers on various platforms, such as E-Mail, Social Media Platforms, Phone Calls, Mails, External Partners, and the MHRA.
To provide a warm, welcoming and safe environment and ensure a high quality of physical, emotional, social and intellectual provision is made for children in the school. My primary responsibilities include: 1. To assist the teacher in the education process by working directly with children in the classroom, including participating in relevant curriculum planning, training, and learning activities, as appropriate. 2. To ensure that a high-quality learning environment is maintained for children with speech, language and communication needs. 3. To ensure the care and welfare of children including those with special educational needs, under the direction of the Headteacher or a designated teacher. 4. To assist the teacher in maintaining a safe environment, through ensuring adequate supervision and discipline of pupils. 5. To establish and maintain appropriate contact with parents, specialist support staff, and other adults involved in the education of children. 6. To assist the teacher in maintaining appropriate records and undertaking associated administrative tasks. Training: 1. Child Protection 2. Epipen & Buccal Training 3. Career Development Programme on Marking and Feedback 4. Career Development Programme on The Teaching of Writing 5. SEN: Special Educational Needs 6. Supporting Wellbeing, Emotional Resilience and Learning (SWERL) These responsibilities were carried out by aiding the teachers and leadership team, as well as through direct interaction with students. The goal was to contribute to the overall success of the students and the school.