TalentSource Life Sciences, a division of CROMSOURCE, is currently looking for a senior person with proven leadership experience to handle a full lifecycle management and post marketing late phase studies to join a Global, leading pharmaceutical company located in Brussels, Belgium.
Our client is a world leader, mainly working in the fields of neurology and immunology. Working with both scientists and academics across the globe, they have a focus on new products and a strong science based approach.
The Regulatory Affairs Expert supports the Regulatory Lead in planning and executing the necessary regulatory activities to progress the Project portfolio with the ultimate aim of obtaining marketing authorisations globally. 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
Our benefits when working in Belgium
- 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
- Clinical trial experience (Late phase clinical trial is a bonus)
- Development experience is also an advantage
- 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
- Handle major variations with the Regulatory team: eCTD content, modules review/input, responsible for Module 1, submission planning, label update.
- 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
Who will you be working for? About CROMSOURCE
- Dedicated Line Manager
- Monthly meetings with line manager
- Employee satisfaction survey - your feedback is important for continuous improvement
- Annual appraisals development planning
- Yearly team event
- New Year's diner
- Group and hospitalisation insurance
- Electronic meal vouchers
- Internet reimbursement
CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do. Our Company Ethos
Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values are evidenced by our below industry average turnover rates. About TalentSource Life Sciences
TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your Line Manager, who will work closely with you to mentor and support your professional development and growth. For our client-facing positions, you must be confident, be able to drive the role and work autonomously. The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
If you would like to discuss the role before applying through the website @ https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00002300
or please contact Rocio.EgeaMota@cromsource.com for more information.
CROMSOURCE is an equal opportunities employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status. Keywords:
Regulatory Affairs Expert
Skills: CRO, Global Regulatory Affairs, Marketing authorizations, Pharma, Pharmaceutical Location: Belgium, Brussels area Share:
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