Hybrid Senior Manager, Regulatory Affairs - Oncology

Medella Life; Massachusetts; Hybrid; USD 100,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Annual bonus

Equity package

Job summary

Medella Life is seeking a Senior Manager of Regulatory Affairs to develop strategies for oncology programs in a clinical-stage biotech setting. Responsibilities include leading regulatory submissions, partnering with cross-functional teams, and ensuring compliance with FDA regulations. Candidates should have a Bachelor’s degree and over seven years of experience in Regulatory Affairs, specifically in the biotech industry. The role offers a competitive compensation package with a hybrid work schedule requiring 2-3 days on-site in Massachusetts.

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 7+ years of Regulatory Affairs experience within biotech or pharmaceutical industry.
• Strong experience supporting INDs and clinical-stage oncology programs.
• Familiarity with FDA regulations, ICH guidelines, and global regulatory requirements.

Responsibilities

• Support regulatory strategy development for oncology programs.
• Lead preparation and coordination of regulatory submissions.
• Partner with Clinical, CMC, Nonclinical, Biometrics teams.
• Coordinate FDA meeting preparation and regulatory correspondence.
• Manage submission timelines for high-quality regulatory deliverables.

Job description

Medella Life is seeking a Senior Manager of Regulatory Affairs to develop strategies for oncology programs in a clinical-stage biotech setting. Responsibilities include leading regulatory submissions, partnering with cross-functional teams, and ensuring compliance with FDA regulations. Candidates should have a Bachelor’s degree and over seven years of experience in Regulatory Affairs, specifically in the biotech industry. The role offers a competitive compensation package with a hybrid work schedule requiring 2-3 days on-site in Massachusetts.