Senior Regulatory Manager - Development

We are currently partnering with a medium sized Pharma company looking to hire a Senior Regulatory Manager. The position will 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. There will be line management responsibilities for 3 direct reports as well as product oversight.

Location: Great London office 4 days per week with 1 day working from home

Responsibilities will include:

·        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.

·        Overseeing all licensing activities across product range

·        Ensuring proper licensing strategies are in place for new Marketing Authorisations in defined territories

·        Ensuring proper processes and systems are in place to manage all regulatory activities related to maintaining drug licences

·        Ensuring proper and relevant documentation necessary for applications to relevant authorities is prepared, and properly reviewed against authorities’ requirements

·        Manage the regulatory process from interpretation of Health Authority regulations and guidance through to submission and final approval

·        Develop business optimal product licensing strategies for designated new products and new markets.

·        Independently, manage all regulatory activities related to new drug applications and maintaining drug licences in business-critical territories.

·        Independently, manage all regulatory activities related to one or several projects across products and territories.

·        Develop robust strategies and actively participate in Regulatory strategy meetings related to complex and/or business critical regulatory projects.

·        Independently manage the regulatory aspects and licensing of Orphan Drugs within the designated countries.

·        Obtain robust Marketing Authorisations in the designated countries or geographical area for designated products and independently manage the documentation generation process, submission, assessment, approval and product launch regulatory steps.

·      

Salary: Competitive + Package

For further information please get in touch with our lead consultant Natalie Jones on 0207 183 5059 or email your details directly to natalie@linkfieldgroup.com