Senior Regulatory Affairs Specialist
A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Senior Regulatory Affairs Specialist. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
The successful applicant will report into the UK and Ireland Head of Regulatory Affairs will provide subject matter expertise into the planning and execution of regulatory and product complaint activities for the company. This will include maintaining high quality marketing authorisations for company products as well as regulatory expertise into defining the optimum label.
- Arrange for submissions to be in line with company global regulatory strategy and local market needs
- Work with global regulatory colleagues in the preparation and submission of responses to regulatory authority questions
- Establish a constructive, responsive and assertive relationship with the regulatory authorities through a mixture of formal and informal communication channels.
- To ensure all the Regulatory Affairs activities are conducted within the framework and full compliance of national regulatory requirements, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), company Standard Operating Procedures (SOPs) and Company policies, health and safety requirements, the Medicines Act and Industry Codes of Practice.
- Ensure all relevant company quality management system procedures /processes are adhered to, and develop new or revised written procedures (e.g. SOPs) as required
- Adhere to mechanisms for the orderly retention of regulatory correspondence to enable easy and secure document retrieval
- Participate when required in the review and approval of promotional materials, non-promotional materials, labelling and information items in line with the ABPI Code of Practice and UK statutory regulations.
- Maintain an up to date awareness of the regulatory environment in the UK and Ireland whilst communicating relevant aspects to UK and Ireland as well as Group colleagues.
- Ensure that submissions of marketing authorisations, variations, renewals, periodic safety update reports and relevant clinical trial applications are made to the regulatory authorities in a timely and professional manner.
- Collaborate with relevant persons in company manufacturing and manage the packaging changes derived from variations, renewals and new marketing authorisations to comply with local requirements.
- When tasked, manage the regulatory aspects of the automated packaging process.
- Take responsibility for effective communication on regulatory matters between the UK and Ireland Regulatory Affairs Department and UK and Ireland commercial, medical and relevant Group personnel.
- Participate in regulatory aspects of UK and Ireland pharmaceutical associations such as ABPI and IPHA.
- Provide support to company preparation for any Competent Authority inspections.
- Act as the UK and Ireland Deputy Complaints Manager for managing complaints according to company standards, including the liaison with manufacturing sites, tracking of local complaints and preparing metrics reports on complaints.
- Liaise with Medical Information Administrator or external suppliers to arrange uplift of defective product and transport to a defined manufacturing site.
Skills and Requirements:
- Educated to a graduate degree level in a scientific discipline, with postgraduate studies in either science or business preferred.
- A good understanding/appreciation of the UK commercial and healthcare environment for medicines.
- Good level understanding of GxP requirements (primarily GDP and GMP).
- Good knowledge of current UK/EU regulatory framework for medicinal products.
- Previous experience of managing a quality management system.
- Previous experience of local complaints management.
- At least 3 years' experience in a UK or EU regulatory role (relating to medicinal products).
- Good understanding of quality management systems.
- Demonstrable knowledge of current UK/EU regulatory framework for medicinal products.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Peter Duvall at +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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