CAMPHARM is an International regulatory affairs and drug development Consultancy Company for pharmaceutical, biotechnology and other healthcare companies, with offices in Brentwood in the UK and Callian in France.

CAMPHARM are now looking to recruit a regulatory affairs manager into the Brentwood office.

Regulatory Affairs Manager

A unique and challenging opportunity has arisen to join a company of proven and committed expertise in regulatory affairs, which provide consultancy and hands on assistance to the pharmaceutical, medical device and related industries. The company currently has its Head Office in the South of France with a subsidiary office in the UK based in Essex. The successful candidate will report directly to the Managing Director of the company.  The candidate selected will be responsible for proactively driving the activities in the UK office and helping to develop the expert team to support its client’s projects and products.   The individual will be expected to contribute to the management and delivery of projects, advising client companies on development/submission strategy and would be responsible for hands on provision of preparing high quality documentation and managing regulatory activities to support the regulatory needs of the client. They would also be actively involved in helping to develop the business for the UK office.

It is envisaged that the successful candidate will have a minimum of a BSc in a relevant life science discipline a broad regulatory experience with a good understanding of European regulations as well as post marketing experience in the EU & beyond.

Essential attributes:

• Minimum of 5 years broad regulatory experience
• Some experience in managing teams, although for the right candidate this could be a career development activity over time.
• The successful candidate will set the European regulatory strategy and project planning for all products/projects of current and future clients
• Demonstrated track record of managing regulatory filings and regulatory procedure management in Europe.
• Experience driving best regulatory practice with internal team experts and outside third party providers
• A desire to manage and develop a regulatory team as the business grows in the UK office
• A good knowledge of IT and proficiency in the relevant software packages used in regulatory affairs documentation and an interest in developing their IT proficiency with other software packages which are required in business administration.
• Experience of managing the preparation of electronic submissions such as eCTD and NeeS
• A desire to be actively involved in business development activities

Responsibilities include:

• Regulatory strategy development by gathering information and ideas, defining activities, and developing a plan from all personnel involved in the regulatory project.
• Proactively resolving any issues to attain a positive and timely outcome to a regulatory project or activity to a high quality standard
• Educate future internal colleagues and external teams regarding regulatory strategy and implications for the strategies.
• Prepare and deliver presentations for client meetings and training courses
• Prepare clients and other project team members for key regulatory events, such as regulatory submissions (such as CTAs, MAAs, variations etc) or regulatory agency meetings (such as scientific advice)
• Prepare or review and approve submission documentation
• Provide a range of regulatory consultancy to the CAMPHARM team and clients
• Develop productive interactions with EU regulatory agencies, the EU Commission and other relevant organisations
• Ensure compliance with all applicable regulations and internal quality systems
• Project management the preparation, review and publishing of submissions and managing the follow on procedures and approvals for client’s products.
• Manages and contributes to the assembly and/or writing of regulatory documentation.
• Assist in the development of regulatory strategic plans for each assigned project.
• Develop the UK office and line manages relevant staff members over time.

If you are interested in this role, please get in touch with us here.