Responsible for strategic and operational regulatory input for cross functional (CMC, non-clinical and clinical) areas in collaboration with other project team members, including CMC regulatory team members.
Contributes to the development of global clinical and regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
Contributes to development of global labeling documents (prescribing information and patient information).
Prepares and/or manages submissions that are technically complex and require extensive interaction with departments outside of regulatory affairs.
Maintains knowledge of highly complex regulatory requirements up to current date and communicates changes in regulatory information to project teams.
Schedules and arranges own activities and those of direct reports.
Work is performed under direction of a Senior Regulatory Affairs professional.

Minimum of 8 years overall regulatory experience, and preferably including experience managing investigational and marketed products.
Bachelors Degree required.
Prior experience representing Regulatory Affairs on cross-functional teams is desirable; Must be capable of effectively leading teams in preparation of submissions.
Experience working on international teams desirable.
Must have an extensive knowledge of regulatory requirements, including ICH and regional requirements, and have an understanding of current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business.
Must be capable of critically reviewing complex technical documents and influencing colleagues across functions.
Experience with drug-device combination products preferred, but not required.
Ability to travel up to 10-20% of the time domestically and internationally.
Must have experience in filing regulatory dossiers including CTAs, IMPDs, INDs required; experience with BLAs/NDAs/MAAs a plus.

Associate Director, Global Regulatory Affairs Clinical Strategy

Key skills