Johnson & Johnson
BE - Regulatory Affairs Manager
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting two Regulatory Affairs Managers to join our contingent workforce on a growing team in charge of CMC regulatory activities related to clinical trials and marketing applications and post-approval CMC regulatory activities related to small molecules in all global markets.
This will be an initial contract opportunity until the end of 2021 with the possibility for an extension for 2022.
DUTIES & RESPONSIBILITIES:
- 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.
REQUIRED KNOWLEDGE AND SKILLS:
- Direct and significant (8-10 years) CMC regulatory experience with CMC documentation preparation for clinical trials (INDs and IMPDs) and worldwide first registrations (NDA, MAA, NDS?), post approval amendments and variation dossiers for small molecules worldwide.
- Strong knowledge of EU and FDA regulations is required, experience with other markets is highly preferred.
- Experience in supporting Health Authority meetings (FDA, EMA and national agencies) preferred.
- Demonstrated ability to manage multiple tasks/projects/priorities and complex systems simultaneously is required.
- Strong interpersonal skills, team player, leadership, conflict management, fast learner and negotiation skills are essential. The candidate must be able to manage and motivate people within a matrix team environment and act as an individual contributor, decision maker, and leader.
- Being fluent in English is a must.
- Flexible working hours.
- You will work remotely because of COVID-19.
- This is a contracting position. You will receive a contract via our partner Ausy. Ausy can offer you a project contract for the duration of the assignment at J&J or a freelance contract.