Associate Director, Regulatory Affairs
Our client is a biopharmaceutical company focused on rare diseases. They have asked us to assist them in their search for an Associate Director, Regulatory Affairs.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Collaborates with other project team member to provide strategic and operational regulatory input for cross-functional areas.
- Contributes to the development of global clinical and regulatory plans and strategies.
- Identifies and proposes risk mitigation strategies.
- 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 up-to-date knowledge of highly complex regulatory requirements.
- 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.
- Must have a minimum of 8 years of overall regulatory experience.
- Experience managing investigational and marketed products highly preferred.
- Prior experience representing Regulatory Affairs on cross-functional teams is highly preferred.
- Must be capable of effectively leading teams in preparation of submissions.
- Experience working on international teams highly preferred.
- Requires extensive knowledge of regulatory requirements, including ICH and regional requirements.
- An understanding of current global and regional trends in regulatory affairs and the ability to assess the impact of these requirements to the business are required.
- Requires the ability to critically review complex technical documents.
- The ability to influence colleagues across functions is required.
- Experience with drug-device combination products highly preferred.
- Requires the ability to travel up to 10-20% of the time domestically and internationally
- Experience filing regulatory dossiers including CTAs, IMPDs, INDs required.
- Experience with BLAs/NDAs/MAAs highly preferred.
If interested, please email your resume as a Word attachment to us. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.