Regulatory Affairs Expert Life Cycle Management
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 ;
- Handle major variations with the project team in alignment with Regulatory Lead: eCTD content, modules review/input, responsible for Module 1, submission planning, label update ;
- Support and deliver quality regulatory submissions in line with the applicable regulations, directives and guidelines, and in line with agreed strategies and timelines ;
- Product development experience: agency interactions (pre-submission meeting, scientific advice ... etc), orphan designation, CTAs, study protocol/IBs/CSR input and review, PIPs ;
- Life cycle management experience ;
- 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.
What we offer
Who we are
Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.
Keyrus Belgium Offices:
- Office Park - Drève Richelle 161 - Waterloo
- Nijverheidslaan 3, - Strombeek Bever