Description:
Regulatory Affairs Expert

Location: Belgium, Walloon Brabant

Schedule: Permanent - Full Time - Office based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently seeking an experienced Regulatory Affairs Expert to support the Regulatory Lead in planning and executing the necessary regulatory activities to obtain marketing authorizations globally.
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.

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

Requirements:

• 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

Our benefits when working in Belgium:

• Competitive Salary
• Group and hospitalisation insurance
• Electronic meal vouchers
• Internet reimbursement
• Company Car with fuel card depending on the function
• Dedicated Line Manager
• Regular face-to-face or phone meetings with line manager
• Full annual performance review process
• Ad-hoc team events and end of year party
• Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
• Employee satisfaction survey - your feedback is important for continuous improvement

If you have the experience needed for this position, please apply directly to https://www.cromsource.com/careers-test/job-vacancies/job-information/?job-id=HQ00001914

If you would like to discuss the role before applying through the website, please contact vanessa.verdickt@cromsource.com for more information.

Why TalentSource Life Sciences/CROMSOURCE:

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.

CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity 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.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Keywords: Regulatory Affairs Expert, Regulatory, Regulatory Quality Submissions

Skills: Regulatory Affairs Manager, Regulatory Location: Belgium