Position:                         Associate Director Regulatory Affairs

Reports to:                     VP Regulatory Affairs

The Client is a Germany & USA based drug discovery firm developing certain compounds based upon and derived from its unique technology. The idea is to take innovative compounds to a certain stage in drug development and then share the results for distribution. The Client is stock based. Possible rewards are high for every individual involved under the assumption that any one of its compounds passes registration.

Tasks:

• Responsible for the conduct, coordination and management of all activities/ procedures concerning International Drug Regulatory Affairs (for given projects).
• Preparation and management of regulatory documents and submissions, e.g. CTAs, INDs, MAAs, NDAs, ODAs, PIPs.
• Ensuring adherence to regulatory requirements regarding drug safety issues.
• Correspondence, planning, coordination, conduct and follow up of meetings with regulatory authorities (e.g EU national agencies, EMEA, FDA).
• Review of all relevant documents submitted to regulatory agencies.
• Maintenance of databases and other software specific to Regulatory Affairs.
• Preparation and review of relevant SOPs.
• Supervision of work of Regulatory Affairs Assistant/Associate.
• Selection and supervision of regulatory consultants;
  Contract negotiations (contract signature by Executive Board  Member) 

Qualification:

• Degree in Life Sciences or Pharmacy, additional qualifications (e.g. PhD, Master of Regulatory Affairs or similar degrees) are advantageous.
• Min. 4 years experience in Drug Development (preferably oncology) and international Regulatory Affairs.
• Excellent command of English and German, additional EU languages advantageous.
• Solid computer skills in standard Microsoft programs; knowledge in document management software (e.g. Documentum) and eCTD publishing software advantageous
• Firm knowledge in CMC, preclinical and clinical matters of drug development (“generalist approach”).

Personality:

• Good communication skills (written and verbal).
• Professional presentation skills. “Hands on” personality.
• Flexibility, open-mindedness, self starter, team-player.