Senior Regulatory Affairs Manager

Headquartered in Hertfordshire, Bio Products Laboratory (BPL) invest in the latest research, technology and manufacturing methods and are continuously supplying high quality plasma-derived products worldwide. We are recruiting a Senior Regulatory Affairs Manager to support the Head of Regulatory Affairs in managing and leading the RA team, the global development (NPD) and the pre-licensing activities.

With substantial experience managing a team in pharmaceutical regulatory affairs you will have the opportunity to proactively contribute to the continuous improvement of the performance of the Regulatory Affairs Department and actively coach members of the Regulatory team to achieve high quality output.

You will oversee all regulatory activities across the New Product Development programs as well as pre-licensing activities across our product range, ensuring consistency in Regulatory Affairs input at all times and ensuring robust and comprehensive global licensing strategies are in place for new Marketing Authorisations in defined territories. These will cover Scientific advice, clinical trials, Orphan drug designation, Paediatric investigation Plan, and possibly early access schemes.

Key duties & responsibilities;

• Deputise for the Head RA in his/her absence where relevant and appropriate.
• Overseeing all Regulatory activities across the New Product Development programs as well as pre-licensing activities
• Proactively contribute to the continuous improvement of the performance of the Regulatory Affairs Department and actively coach members of the Regulatory team to achieve high quality output.
• Responsibility for the line management of a team of permanent members of staff. i.e. managing goals and objectives and training and development. Responsible for managing temporary staff as well as contractors.
• Ensuring proper tracking and planning of team activities are in place to manage all regulatory activities related to the development of new products but also the maintenance of licences under area of responsibility
• Ensuring proper and relevant documentation necessary for applications to relevant authorities is prepared, properly reviewed against authorities’ requirements
• Manage the regulatory process from interpretation of Health Authority regulations and guidance through to submission and final approval.
• Support product launch, tenders, and customers of intermediates.
• Actively maintain information data bases, documentation and procedures to ensure regulatory compliance of BPL products released to market.

Experience to make you successful in the role;

• Membership of TOPRA
• Scientific degree, preferably biological first degree and higher qualification
• Substantial experience of managing a team in pharmaceutical regulatory affairs
• Experience in obtaining and maintaining manufacturing and clinical trial authorisations in UK and worldwide
• Knowledge of current regulations in UK and EU for licensing
• Experience of dealing directly with assessors
  Experience in licensing of biological products
• Knowledge of protein chemistry relevant to licensing of products
• Experience of licensing of pharmaceuticals in US
• Experience of controlling packaging approval process

In return we offer;

• Competitive salary, and benefits to include a performance related bonus
• 25 days holiday
• Pension
• Private Medical Insurance
• Life Insurance
• On-site free parking, with a subsidised restaurant