Regulatory Affairs Lead — INDs/CTAs, Biotech

Kymera Therapeutics, Inc.; Watertown (MA); Ibrido; USD 145.000 - 215.000; Tempo pieno

Descrizione del lavoro

Kymera Therapeutics, a clinical-stage biotechnology company, seeks a Senior Manager, Regulatory Affairs to lead study-level regulatory activities and drive submissions from initiation to filing. You will collaborate across cross-functional teams and manage agency interactions with increasing autonomy in a fast-growing biotech setting.

This role reports to the Director of Regulatory Affairs and requires strong US regulatory knowledge, strategic thinking, and effective communication to support

Competenze

• 5-7 years of drug development experience in regulatory affairs.
• Independently manages regulatory submissions (INDs/CTAs, amendments).
• Strong knowledge of US regulatory requirements; EU CTR/CTIS a plus.
• Excellent written and verbal communication for cross-functional teams.
• Strong critical thinking, prioritization, and problem-solving skills.
• Collaborative team player able to work within regulatory group and with external partners.

Mansioni

• Serve as regulatory representative on study-level cross-functional teams.
• Lead compilation, authoring, and completion of regulatory submission packages (INDs/CTAs, amendments).
• Provide oversight with CRO regulatory groups.
• Review regulatory packages as part of drug release process.
• Draft designation requests (Orphan Drug, Fast Track, Breakthrough) for programs.
• Support health authority interactions and agency engagements; contribute to briefing documents.
• Evaluate regulatory precedents and guidance to inform development planning.
• Maintain awareness of external regulatory environment and share insights.
• Contribute to standard processes and best practices for Kymera's regulatory group.

Conoscenze

Regulatory submissions

IND/CTA experience

FDA meetings

US regulatory knowledge

Cross-functional collaboration

Regulatory strategy

Formazione

Bachelor's degree in life sciences

Strumenti

Regulatory databases

Regulatory submissions software

Descrizione del lavoro

Kymera Therapeutics, a clinical-stage biotechnology company, seeks a Senior Manager, Regulatory Affairs to lead study-level regulatory activities and drive submissions from initiation to filing. You will collaborate across cross-functional teams and manage agency interactions with increasing autonomy in a fast-growing biotech setting.

This role reports to the Director of Regulatory Affairs and requires strong US regulatory knowledge, strategic thinking, and effective communication to support