Global CMC Regulatory Affairs Specialist
You will be CMC Regulatory Affairs responsible for one or more commercial and/or development small molecule compounds for all markets worldwide.
- You will actively participate in several development and other teams
- Post-approval CMC RA activities will include providing direction on the interpretation and application of global CMC regulations and guidelines for CMC changes including country specific requirements, defining regulatory strategy, writing CMC variation dossiers and coordinating responses to Health Authorities (HA)
- Development activities will include: contribution to the preparation and editing of clinical trial and initial marketing applications and coordinating responses to HA; correspondence and direct interaction with HA; development of product-specific regulatory strategy documents; technical review and approval of master protocols, reports and other source documents; and other related duties as assigned
- 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. The candidate must be able 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 (Beerse).
As an answer to your high performance & flexibility, AUSY offers you an interesting salary package, with some interesting extras like:
- Meal vouchers of €7
- Net representation cost of €50
- Hospitalization insurance
- Car + unlimited fuel card OR home-work compensation
- 32 holidays
- End-of-year bonus
- Pension plan
- ECO vouchers
- Opportunities to follow trainings
And on top of this you'll improve your skills and become an even bigger expert!
Do you believe in affordable healthcare? Are quality & safety your priority number 1? Then you'll feel comfortable in this company, who's one of the biggest pharmaceutical companies in the world.
Besides the fact that your experience and expertise will be much appreciated, working at one of the biggest pharmaceutical companies opens many doors to future opportunities!
You definitely need to apply if you're looking for a contract at Randstad Professionals, a project based contract or an opportunity as a freelancer, because it's all possible! Just get in contact with me: email@example.com or call me on +32 2 472 94 70