Associate Director Regulatory Affairs

at  PAION Pharma GmbH

YOUR PROFILE

• A university degree in science or comparable education.
• Formal education in drug regulatory affairs is advantageous
• Background of working in pharmaceutical/biotechnology industries or service providers (CROs) to those industries with a minimum of 5 years’ experience.
• Good working knowledge of EU regulatory framework
• Regulatory CMC Life Cycle Management with respect to business needs
• Working knowledge of EU clinical trials may be useful
• Good self-management
• Strong sense of responsibility
• Attention to detail
• Ability to connect with internal departments and external partners.
• Advanced level in written and spoken English.

ABOUT US

PAION Pharma GmbH, headquartered in Aachen, Germany, is a specialty pharmaceutical company in the field of anaesthesia and critical care specialising in innovative active pharmaceutical ingredients for use in outpatients and hospitals.
PAION Pharma GmbH is part of the Humanwelll Healthcare Group.

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