Manager, Regulatory Affairs, Europe (Inflammation)

Job Description:

This is an important role that will support drug development regulatory affairs for a priority project that is in a Phase II-III development. You will bring established experience in the regulatory environment and in the pharmaceutical or biotechnology industry. Team work will be very important as you will interact with project teams at a regional and global level, so you will demonstrate this capability as well as very strong communication skills.

Responsibilities will include, but are not limited to, the following:

• Work with Global Regulatory Functional team and EU/International Regulatory Strategy Leaders to implement plans pre-licensing and post-licensing projects in the EU and International region.

• Provide support to Regulatory Functional teams for the preparation of submissions, which may include Clinical Trial Applications, Briefing Documents, Orphan Drug Applications, Variations and Marketing Applications, etc.

• Maintain and update knowledge of the EU and International Regulatory procedures and guidelines.

• Participate in Regulatory interactions with EU and International Regulatory Agencies, including the EMEA on assigned projects

• Work with the Operations team to prepare EU and International Regulatory documents in electronic and paper format.

• Identify issues that will impact programs and work with regulatory colleagues to provide strategies for dealing with them.

• Participate or act as EU regulatory representative on various cross-functional teams

Skills/Knowledge Required:

• Degree/higher degree in scientific discipline;
• Experience in Inflammatory Disease Drug Development preferred.
• Proven regulatory affairs experience. Established European experience is required. Experience of working in a global project environment an advantage.
• Good Understanding of the laws, regulations and guidelines related to drug development.
• Specific expert knowledge in one or more key areas expected: Inflammatory Disease Drug Development / Quality / Nonclinical / Clinical / Labelling / Promotional
• Inter-dependant partnering skills, team-orientated with the ability to influence outcomes are necessary skills in the environment.
• Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously.
• Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail
• International travel may be necessary