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CMC Regulatory Manager
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Marketing
Projektbeschreibung
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.
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.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Marketing/Vertrieb, Sonstiges