We are a newly licensed, west coast-based US subsidiary of a European pharmaceutical company that is seeking to hire a Head Regulatory Affairs US.  This position will be US-based, and have responsibility for all FDA related activities, including review and filing of ANDA applications and on-going contact with the FDA for all correspondence related to the ANDA applications.  The position reports to the Director International Regulatory Affairs and will serve as the registered US agent, if required, for the two FDA inspected and compliant foreign establishment registrations where a broad range of FDF products will be manufactured for US import and distribution in the US retail and institutional markets.

Key requirements and responsibilities:

• The position will be responsible for all ANDA submissions, with demonstrated ability to write, compile and publish according to the eCTD content, format and specifications, including the bookmarking and hyperlinking of the documents into FDA compliant documents to be submitted via the Electronic Submission Gateway (ESG) to the FDA
• Coordination and follow-up with corporate regulatory, Quality and R&D personnel to ensure that all supporting documents and responses are made in the appropriate format to support the company’s projected ANDA filing and approval dates.
• Ability to compile, organize and publish responses to issues, questions and deficiencies presented by FDA
• Responsible for establishment registration, self-identification, labeler code request, SPL preparation and drug listing, MA maintenance activities
• Responsible for submission and follow up of controlled correspondence, briefing books as may be required, and all meeting requests with the FDA
• Willingness to undergo state and federal level background check, if required

Prior Experience and Competencies:

• College degree with a specialization in a life science. A master’s degree preferred.
• Prior credentials in a senior management position in regulatory affairs with direct experience and oversight of all FDA related matters
• Ability to communicate and correspond by email and virtual meetings/conference calls; strong written and verbal communication skills are required
• The ability to self-motivate and work efficiently in a remote or small office setting
• Supervisory level experience is also desirable in one or several of the following work disciplines:
  • Quality assurance
  • Operations control, supply chain
  • Project management