Regulatory Affairs Consultant

仕事内容

Location: Belgium, Antwerp area - Home and Office based
Schedule: Full Time, Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it’s the best of both worlds….

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a Regulatory Affairs Consultant to join one of our partner companies. Our client is a global biopharmaceutical company which brings therapies to people that extend and significantly improve their lives through the discovery, development and manufacture of healthcare products.

CROMSOURCE is an international CRO with a strong focus on quality, professional development and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

Scope of the role:
As a Regulatory Affairs Consultant, you will be part of a team that will guide the company by interpreting federal, state and international regulations as they apply to products, processes, practices and procedures. In this role you will be responsible for product registration activities of the assigned products and will report to the Regulatory Strategy Sr Manager. You will work in cross-functional teams with different departments (manufacturing, labs, QA, supply,…) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC) in order to support the introduction of new products at site. It is your hard work and dedication that will make the company ready to achieve new milestones and help patients across the globe.

Main Job Tasks and Responsibilities:

• Support regulatory submissions of the products by informing site colleagues of regulatory requirements and by authoring the dossier
• Liaise with regulatory colleagues to communicate and resolve potential issues
• Collaborate across the network of other stakeholders to deliver high quality CMC submission and ensuring compliance of the company portfolio.
• Manage timely responses to Board of Health requests resulting from lifecycle submissions in markets or products under responsibility
• Assess Post approval changes at the manufacturing site and the associated regulatory variations. You are responsible for authoring the impacted sections of the dossier
• Contribute to the completion of projects, manage own time to meet agreed targets and develop plans for work activities within a team to support operational goals

Education and Experience:

• Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,...)
• Experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience in regulatory (authoring Common Technical Document (CTD), Biologics license Application (BLA)) and quality
• Scientific knowledge, analytical skills associated with technical writing skills to issue regulatory documentation
• Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA)
• CMC experience is a real asset

Skills:

• Ability to communicate effectively verbally and in writing, good negotiation and influencing skills
• Dynamic, flexible, enthusiastic and eager to learn
• Ability to work under minimal supervision and in a team
• Fluent in written and spoken English. Preferably, your second language would be French or Dutch

The Benefits of Working for TalentSource 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

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.

Who will you be working for?

About CROMSOURCE
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.

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 Consultant, Regulatory Affairs, CRO, Contract Research Organisation, Outsourced, Outsourcing, Sponsor-dedicated

Job Type: Permanent

Benefits:

• Hospitalization insurance
• Internet reimbursement

Schedule:

• Monday to Friday

Education:

• Master’s (Required)

Experience:

• Regulatory: 4 years (Required)
• CMC: 4 years (Preferred)