Regulatory Affairs Executive

About the role

Regulatory Affairs Executive - North West England Office/Home Based

Our client is a privately-owned Company which allows them the freedom to decide which research they invest in. They have a strong code of ethics and conduct and have a commitment to ethical and social responsibility. They have medicines within Cardiovascular, Neonatal, Transplantation, Respiratory, and have an exciting speciality pipeline.

Your role will be to maintain product licences held by the Company, ensuring new licence applications are submitted appropriately and that licences are kept up to date by appropriate maintenance applications with the relevant Regulatory Authorities.

Key responsibilities include:

• Preparation and submission of applications for new Marketing Authorisations, renewal, variation and change of ownership to the Regulatory Authorities
• Preparation and publishing of regulatory submissions within eCTD format and update of the Regulatory Information Management System (RIMS)
• Prepare responses to questions issued by the Regulatory Authorities
• Follow up with Regulatory Authorities on submissions and regulatory issues
• Request, review and submit all PSURs as required
• Direct negotiations and liaisons with 3rd party companies and other departments of the company concerning submission applications
• Writing, reviewing and advising on SmPCs and packaging

Candidate profile:

• Experience of working in a pharmaceutical regulatory/licensing environment
• Working knowledge of Regulatory Affairs legislative procedures and processes
• Good communication and interpersonal skills
• Ability to work well in a team environment
• Good planning and organisation skills
• High-level attention to detail and accuracy
• Strong IT skills, including MS Excel, Word and Powerpoint
• High standard of literacy and written communication

An excellent salary and benefits package will be offered.

Please apply online or contact CHASE for further information on 0131 553 6644.

Reference Number: 57226