Senior Manager Regulatory Affairs

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

We are currently supporting a clinical-stage oncology biotech focused on developing targeted therapies and next-generation immuno-oncology treatments across solid tumour indications.

With multiple assets in Phase I/II development and continued pipeline expansion, the company is seeking a Senior Manager, Regulatory Affairs to support regulatory strategy and execution across key development programs.

Responsibilities

• Support regulatory strategy development for oncology programs from IND-enabling activities through clinical development
• Lead preparation and coordination of regulatory submissions including INDs, amendments, annual reports, briefing packages, and CTA support
• Partner closely with Clinical, CMC, Nonclinical, Biometrics, and Program Management teams to support development milestones
• Coordinate FDA meeting preparation, background packages, and regulatory correspondence
• Manage submission timelines and ensure high-quality, on‑time regulatory deliverables
• Review protocols, investigator brochures, informed consent forms, and study‑related documents from a regulatory perspective
• Track and interpret evolving FDA and global regulatory guidance relevant to oncology drug development
• Support publishing activities and submission readiness for eCTD filings
• Contribute to regulatory risk assessments and long‑term development planning

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
• Experience working within fast‑paced clinical development environments

  Preferred Background

  • Oncology, immuno‑oncology, cell therapy, or targeted therapy experience strongly preferred
  • Advanced degree (MS, PhD, PharmD, or RAC certification)
  • Experience supporting FDA meetings and interactions
  • Familiarity with eCTD submissions and regulatory systems
  • Hybrid schedule with 2–3 days onsite in Cambridge, MA
  • Competitive compensation, annual bonus, and equity package
  • Visible role within a growing Regulatory Affairs organization supporting an expanding oncology pipeline