Description:
Regulatory Affairs Manager

Location: Belgium, Brussels area

Type of Contract: Permanent - Full time - Office Based

TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Manager for the Brussels area to join our client-based team at one of the leading global biopharmaceutical companies. 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 scope of this role includes the following:

• Manage Clinical Trial Applications (CTA's) in EU and provide operational regulatory support and guidance in cross-functional clinical trial teams (internal and external).
• Manage clinical trial submissions to agreed project targets, and oversee the work of the assigned Contract Research Organisation (CRO).
• Work flexibly within the EU team to provide broad operational for initial clinical trial applications, Q&A with Authorities/Ethics Committees, study maintenance, amendments, trial closure activities and archiving of trial documents.
• The ideal candidate also has experience with assisting in the review and preparation of protocol/IB/IMPD and other CTA documents.

Main tasks and responsibilities:

• Support the EU Regulatory Science Lead (RSL) and assist in the planning, preparation and delivery for the delivery of timely Clinical Trial Applications and approvals, in compliance with relevant UCB procedures and regional/local country regulations.
• Represent the EU Regulatory team in cross-functional workstreams to provide regulatory expertise on clinical trial submissions, and liaise proactively with the functions and participate as a member of cross-functional delivery teams (internal and external)
• Ensure that appropriate, up-to-date records are maintained for compliance in UCB's document management systems

Requirements:

• Master's or Bachelor's Degree
• 2-5 years hands-on experience with Clinical Trial Applications in EU, with knowledge of assigned regional regulatory procedures and legislation

Skills:

• Build effective partnerships - identifies opportunities and takes actions to build effective relationships within team and with other areas
• Effective communication skills
• Flexibility and adaptability - decides what to do based on the situation. Works effectively in ambiguous situations.
• Results focused - ability to overcome obstacles and achieve key outcomes
• Analytical - logically breaking situations or issues down into their essential elements: carrying out diagnosis and developing solutions
• Organisational Skills
• Integrity - overriding commitment to integrity and high standards in self and other

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.talentsourcelifesciences.com/job-information/?job-id=HQ00002001
If you would like to discuss the role before applying through the website, please contact Rocio.EgeaMota@cromsource.com for more information.

Why choose 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 Scientist, Regulatory Affairs Manager, Clinical Trial Submission

Skills: Regulatory Affairs Manager, Scientist, Regulatory Location: Belgium Share:

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