I am urgently recruiting for a motivated Regulatory Affairs Specialist (CMC) to join a leading Biotech in Beerse, Belgium (partly remote).
The primary responsibility is to support the post-approval CMC regulatory activities related to small molecules in all global markets.
- Support teams, including representing CMCRA in meetings 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)
- 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
- 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).
- Duration: End of the year (extension possible)
- Start date: ASAP
- Remote work possible, max once a month on site (Beerse).
Please apply with your CV. For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at email@example.com
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