The Associate Director Regulatory Affairs is responsible for establishing and implementing the regulatory CMC 
strategy for PAION in cooperation with other relevant functions (locally and globally). This person ensures the update of the CMC dossier in a timely manner by authoring and reviewing relevant M1, M2 and M3 documentation. 
In addition, the job holder establishes and maintains Drug Master Files in various non-European territories in cooperation with local partners. 
The Associate Director Regulatory Affairs is expected to provide in-depth scientific and regulatory support to the other departments, partners and licensees as needed.

• Management of CMC dossiers
• Management of DMF dossiers in various countries 
• Drafting of M1 to M3 CTD submission documentation
• Regulatory support of commercial products 
• Strategic variation management
• Drafting of Investigator Brochures or IMPDs
• Review of SOPs owned by other departments with RA interface
• Drafting of RA SOPs
• Drafting of Authority meeting documentation
• Coordination and support of regulatory authority interactions (pre-submission meetings, scientific advice, authority questions etc.)
• Regulatory support of license partners