Remote Regulatory affairs Jobs · FDA Regulations

• Develop and implement global regulatory strategies for oncology programs from early development through post-marketing.
• Lead preparation and submission of INDs, NDAs, and other regulatory filings to ensure compliance and quality.
• Provide strategic regulatory guidance and cross-functional collaboration to drive program success.

Deciphera is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines for cancer, neurologic and autoimmune disease. They cultivate an inclusive culture that values curiosity, creativity, and shared accountability, empowering individuals to challenge the unknown together.

• Execute regulatory oversight for advertising, promotion, medical communications, and labeling across the product lifecycle.
• Provide proactive regulatory strategy and risk-based guidance to commercial and medical review committees.
• Lead FDA OPDP/APLB interactions and cross-functional labeling negotiations with health authorities.

Kyverna Therapeutics is a biopharmaceutical company developing cell therapies for autoimmune diseases. It is a growth-stage biotech with a collaborative, solutions-oriented culture and a focus on regulatory excellence.

• Lead and supervise a team of regulatory specialists managing labeling approvals, drug listings, and medical device submissions.
• Oversee FDA compliance, quality investigations, and health hazard evaluations to ensure product integrity.
• Collaborate cross-functionally with Quality Assurance, Legal, and external partners to resolve complex regulatory challenges.

The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.