Large Pharmaceutical company in Belgium are looking for an experienced Regulatory affairs expert (Early development) for an initial 6-month contract but likely to extend into 2021

The role can be performed mainly remotely with occasional trips to the Belgium or UK / Middlesex office

Major Accountabilities and Responsibilities

• Contact person for assigned responsibilities on the product, in alignment with Regulatory Lead
• Assume responsibilities for contact with 3rd party partners (mainly CROs), building strong relationships for assigned project(s), in line with the Regulatory Lead
• Responsible for providing regulatory expertise and strategy, in alignment with the Projects
• Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines.
• Ensure that all documents and information are adequately captured in a timely fashion in the applicable systems (document management, databases, etc).
• Prepare and communicate regulatory strategic and operational plans for assigned projects
• Maintain awareness of external regulatory environment, new guidelines and legislation

Required qualifications

• Experience of EU regional regulatory procedures and legislation related to drug development and clinical trial applications. From 5 to 10 years of global experience preferred in this field.
• Strategic and results focused - ability to overcome obstacles and achieve key outcomes
• Strong Project planning and management skills, being able to perform risk assessments, anticipating problems and providing creative solutions.
• Analytical - logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
• Integrity - overriding commitment to integrity and high standards in self and others
• Flexibility and adaptability - Decides what to do based on the situation. Changes behavior or approach to fit the situation or the person.  Works effectively in ambiguous situations.
• Facilitates and coordinates teams and processes with appropriate use of interpersonal skills
• Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas
• Influencing skills - through well thought through rationale and effective communication skills, able to influence key decisions
• Communication skills - knows when and how to communicate, using strong interpersonal skills and written communications when appropriate
• Sensitivity to the diverse cultures comprising- the international and global environment

To incapsulate the role, we are looking for a Regulatory Affairs Expert with at least 5 years of experience, mostly in Early development / Product development (early phase) giving scientific advice, the client are NOT looking for strong CTA or Post marketing products

Please call me or email me for more details on this urgent opportunity

Glenf@msigroupltd.com 02079401212