Beschreibung
Randstad Professionals is actively looking to find an open-minded and motivated candidate to join our client in Basel, Switzerland.
We are looking for a person with two or more years of working experience in pharmaceutical CMC regulatory affairs to support our client's team.
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 systems and databases
Minimum Requirements
-The candidate must possess an University degree in chemistry, pharmacy, life sciences or equivalent
-2 years or more 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 speaking and written skills are required
If you are interested and up for a new challenge, don't hesitate to contact me!