MSI Pharma have partnered with a global pharmaceutical organisation in the US who are seeking a Global Regulatory Director to spearhead transversal projects for the success of the business and company goals.
Responsibilities
- You will ensure the development of robust regulatory strategies for multiple products and will be accountable for developing and maintaining global regulatory strategy documents.
- You will be responsible for prioritizing projects and activities with the Global Regulatory Team for lifecycle management activities (i.e. renewals, variations, new registration expansions).
- You will work with the Global Regulatory Team to develop and maintain the core dossier/Product Reference File.
Experience
- Direct interaction/negotiation skills with regulatory authorities (e.g. FDA, EMA, Health Canada, PMDA, Chinese HA etc.)
- Understanding of the Global (including CA, US, EU, WHO, China, Japan in particular) and pharmaceutical market place and familiarity with medical terminology.
- Ability to work well within cross-functional teams and excellent transversal collaboration skills.
- Strong sensitivity for a multicultural/multinational environment.
Qualifications
- PhD, Pharm D or MSc in Biology or Life Sciences
- Minimum of 5 years of experience of Global Regulatory Affairs experience
- Experience of vaccines, microbiology, immunology, virology or bacteriology in development phase
- Experience in mRNA is a bonus
