Regulatory Affairs Senior Scientist

As the Regulatory Affairs Senior Scientist, your job purpose is to

• Perform all aspects of Regulatory Affairs as may be globally applicable to products of any regulatory classification, assigned to the “Pharma” division, but particularly focused on medical devices, cosmetics or food supplements.
• Ensure continued regulatory compliance and product availability, particularly with respect to product licensing and associated approvals.
• May include the supervision and training of staff regarding workload and task allocation

What you’ll be doing

• Ensure the effective management of product approvals, regulatory information, systems and processes, including the analysis and transformation of data into relevant formats e.g. Technical File creation and maintenance, Notified Body submissions, PIF creation. Prepare, QC check, submit and track documents and applications.
• Operate internal and external electronic and physical product information repositories, including portals, trackers, databases, files and archives as required for the effective management of product approvals and subsequent placement on the market.
• Identify and participate continuing professional development, to maintain currency of regulatory knowledge.
• Ensure personal and departmental activities comply with applicable regulatory standards and the QMS. Manage and prioritise activities to meet agreed timelines.
• Develop and maintain effective relationships with internal and external partners, including regulatory / licensing authorities.
• Assist in the implementation of changes in working practices to meet corporate strategy or provide other improvements. May lead some or all changes associated with a specific outcome.
• Represent Alliance Pharma Division on acquisition and disposal due diligence and integration projects.
• Deputise, as appropriate, for the Regulatory Senior Manager – Pharma Division

What we are looking for

• A bachelor’s degree or equivalent in a life or physical science, engineering or similar related field.
• Extensive experience in Regulatory Affairs within healthcare industry, including medical devices.
• Proven track record of successfully delivering global regulatory approvals and related authorisations, including UK and EU.
• Strong project management skills, including planning, scheduling and risk management.
• Familiarity with all regulatory application processes for healthcare products, particularly medical devices.
• Familiarity with the operation of electronic and physical product information repositories, including databases and file submission, as required for the effective management of product approvals and subsequent placement on the market.
• Excellent communication, presentation and stakeholder management skills.
• Strategic thinking with a hands-on approach to application management.
• Comfortable working in a regulated global environment.
• Strong interpersonal skills and the ability to influence without authority, manage conflict and foster alignment across diverse teams.
• Proficient in written and spoken English.