Regulatory Manager - Global CMC
Proclinical are partnered with a house-hold pharmaceutical business, who are looking to further strengthen their CMC division with a new Regulatory Manager.
You will be supporting all Regulatory CMC Activities across a vaccines portfolio for an initial duration of 12 months.
Skills and Requirements
- Direct and significant regulatory experience with vaccines and in CMC documentation preparation for late phase INDs and IMPDs, BLAs and MAAs for vaccines highly preferred.
- Strong knowledge of EU and FDA regulations is required, experience with other markets is added value.
- 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, teamwork, 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 as an individual contributor, decision maker, and lead
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.