Director, Regulatory Affairs

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Job description

Description:

About Rockwell Medical

Rockwell Medical [Rockwell] is a biopharmaceutical company dedicated to transforming iron deficiency and anemia management in a wide variety of therapeutic areas and across the globe, improving the lives of very sick patients. The Company's initial focus is the treatment of anemia in end-stage kidney disease. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for maintenance of hemoglobin in hemodialysis patients. Rockwell Medical is also an established manufacturer, supplier and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad.

Job Summary

The Director, Regulatory Affairs will be responsible for the development and implementation of regulatory strategies for post market approvals of new indications for Triferic. In addition, the Director will be a voting member of the Medical, Legal, and Regulatory review committee whose mission is to review, approve, and or make recommendations for revisions to promotional and advertising materials to ensure compliance with FDA promotional regulation requirements.

Job Duties

· Develops and implements regulatory strategies in cooperation with the CDO & CMO

· Develops effective professional relationships and promotes a positive company image for Rockwell with FDA and global regulatory authorities.

· Identifies and assesses regulatory risks and assists in developing mitigation strategies

· Participates in regulatory interactions with US FDA and other regulatory authorities.

· Develops tactical work plans including regulatory filings for approvals, e.g. new indications and delivery devices for Triferic

· Provides guidance to the commercial team (Sales & Marketing) regarding compliance aspects of promotional materials, programs, and practices.

· Proactively ensures compliance with all relevant regulations and guidelines.

· Interacts with Quality management to ensure appropriate policies and procedures.

· Provides guidance to the organization regarding new/updated FDA & global requirements.

· Complies with all applicable policies regarding health, safety, and environmental policies

. Requirements:

Job Requirements

· MS in life sciences or related area and at least 10 years of experience in regulatory affairs in a pharma or biotech organization, with 7+ years in a management role.

· Proven experience with US FDA submissions : IND + NDA

· Advanced knowledge and experience in the drug development process

· Demonstrated understanding of ICH guidances and processes as they apply to drug development.

· Broad working knowledge of GCP,GLP,GMP, and Promotional rules

· Demonstrated outstanding communication skills, including presentation, written, and interpersonal.

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