Offer summary

Qualifications:

Bachelor's degree in Life Sciences or related field; advanced degree preferred., Extensive experience in regulatory affairs, particularly in labeling and strategy., Strong understanding of FDA regulations and guidelines., Excellent communication and leadership skills..

Key responsibilities:

Develop and implement regulatory strategies for product labeling.

Collaborate with cross-functional teams to ensure compliance with regulations.

Prepare and submit regulatory documents to health authorities.

Lead meetings with stakeholders to discuss regulatory issues and strategies.

We're focused on discovering and developing novel investigational medicines to treat genetically defined diseases through scientific leadership in the field of cellular metabolism. Our most advanced drug candidate is a first-in-class pyruvate kinase R (PKR) activator, mitapivat, that is currently being evaluated for the treatment of three distinct hemolytic anemias. In addition to our active late-stage clinical pipeline, we have multiple novel, investigational therapies in clinical and preclinical development. We’re a company that cares about our work, each other, and the people who are counting on us the most. We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results.

Required profile