Location: Belgium - 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 Specialist for one of our clients, a TOP pharmaceutical company in Belgium.
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.
Main Job Tasks and Responsibilities:
- Support the post-approval CMC regulatory activities related to small molecules in all global markets
- Support teams, as needed and provide direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements, define regulatory strategy, write CMC variation dossiers and coordinate responses to Health Authorities (HA)
- Additional responsibilities might include: renewal variations (as requested), development of product-specific regulatory strategy documents; technical review and approval reports and other source documents; change controls and other related duties as assigned
Education and Experience:
- Direct and significant CMC regulatory experience with post approval amendments and variation dossiers for small molecules worldwide
- Strong knowledge of global/worldwide regulatory guidelines and regulations is required
- Experience in supporting Health Authority meetings (FDA & APAC is a plus, EMA is a must) preferred
- Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required
- Strong interpersonal, teamwork, leadership, conflict management, fast learner and negotiation skills are essential
- Ability to motivate people within a matrix team environment as an individual contributor, decision maker, and leader
- Excellent knowledge of English (written & spoken)
- Remote work possible, max once a month on site
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
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/jobs please contact email@example.com for more information.
Who will you be working for?
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 Specialist, Regulatory affairs, Regulatory, Clinical Research, Pharma, Pharmaceutical, CRO, Contract Research Organisation, Outsourced, Sponsor-dedicated
Regulatory Affairs Associate, Clinical Research Organisation, CMC, CRO, Pharma, Pharmaceutical, Regulatory