Beschreibung
Our client, a global pharmaceutical company is looking for an experienced Project Manager Process Development, to support their site in the greater Basel area.Start: As soon as possible
Duration: 6 months +
Location: Basel area, Switzerland
Role and Responsibilities
• The CMC Regulatory Manager in Small Molecules Marketed will be responsible to support global CMC regulatory teams to help write CMC sections of post-approval marketing applications, support renewal and answers to deficiency letters.
• The individual will support and facilitate review of submissions by collecting comments from the CMC team and reviewers, leading review discussions, and modifying documents.
• The individual will support Technical Regulatory Leader to maintain system and databases.
Requirements
• Education: University degree in chemistry, pharmacy, life sciences or equivalent
• Proven experience in pharmaceutical CMC regulatory affairs, formulation development, quality or analytical development is required; experience post-approval submission is advantageous.
• Must be detail oriented with excellent interpersonal skills.
• Languages: Good English language skills (oral and written) are required.