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THE POSITION

You will be responsible for managing the product registration chain, compliance with regulatory authorities and Global Regulatory Affairs (RA), maintenance of product authorisations/licences, and relevant LCM (life cycle management) activities.

TASKS & RESPONSIBILITIES

• Provide full regulatory support for assigned licensed products in UK, Ireland and Malta across the full life cycle, from pre-launch, launch, maintenance, discontinuation, and divestment. Includes the preparation and submission of licence variations, implementation of SPC, datasheet and artwork updates, and preparation and implementation of prescribing information.
• Maintain corporate and local regulatory databases (e.g., BIRDS, DAVID etc.) and departmental tracking and filing systems to ensure accurate and retrievable records of department activities.
• Provide regulatory input on status to brand or trial teams, or other local or corporate colleagues.
• Take responsibility for completion of assigned training and own development, develop and maintain an up to date knowledge and awareness of regulatory requirements and developments, and apply these within the sphere of own role.
• Contribute to the completion of corporate and local initiatives and projects and to process improvements within the department, including input to the drafting and updating of documented processes.
• Support audits and inspections and the investigation of non-compliances or other issues.
• Responsibility for reviewing and providing guidance for assigned promotional documents and activities that is timely, accurate and consistent.

REQUIREMENTS

• Experience of working in a Regulatory or Technical role within the pharmaceutical industry is desirable but not essential
• Ability to prioritise workload on a daily basis and maintain an up to date plan of ongoing and future work.
• Ability to manage a heavy and varied workload with possible conflicting and changing deadlines and respond quickly and positively to changes, showing a flexible can-do attitude.
• Ability to work independently and pro-actively but also to identify when additional support or input is needed.
• Good team player, willing to share advice and experience across the department and with other teams.
• Excellent written communication skills with attention to detail. Ability to interpret and summarise guidelines and scientific information. Written communications are concise and clear.
• Strong interpersonal skills, able to interact and engage with internal and external stakeholders.
• Strong IT skills and aptitude for working with databases

WHY THIS IS A GREAT PLACE TO WORK

Boehringer Ingelheim has been recognised as a Top Employer in the UK. Being certified as a Top Employer confirms our dedication to a better world of work, delivered through excellent HR policies and people practices. To learn more visit: https://www.boehringer-ingelheim.co.uk/careers/uk-careers/why-great-place-work

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