Senior Regulatory Specialist

Dew Software; Boston (MA); Sur place; USD 96 000 - 152 000; Plein temps

Résumé du poste

Dew Software, Inc. is seeking an experienced US Regulatory Affairs Lead to support regulatory strategy, submission activities, and cross-functional collaboration for innovative pharmaceutical programs in the oncology space.

Position: US Regulatory Affairs Lead. Contract Duration: 6 months, with potential extension. Schedule: 40 hours per week, Monday–Friday. Travel: Little to no travel expected.

Qualifications

• Bachelor’s degree in a relevant scientific discipline; advanced degree preferred.
• 7–10+ years of Regulatory Affairs experience in pharma/biotech.
• Strong knowledge of US FDA requirements and submission procedures.
• Hands-on experience with IND, NDA, and/or BLA submissions.
• Excellent communication, project management, and cross-functional collaboration skills.

Responsabilités

• Support US regulatory strategy and execution for new products and indications.
• Prepare and contribute to FDA meeting materials, regulatory research, and regulatory intelligence.
• Lead or support IND, NDA, and BLA submissions to the US FDA.
• Collaborate with Clinical, Global Regulatory, and other cross-functional teams.
• Develop and coordinate regulatory submission processes and documentation.
• Support regulatory assessments of external innovation opportunities.

Connaissances

Regulatory strategy

FDA submissions

Project management

Cross-functional collaboration

Formation

Bachelor’s degree in a relevant scientific discipline

Advanced degree preferred

Description du poste

Are you an experienced Regulatory Affairs professional with strong knowledge of US FDA regulations and drug development submissions? This could be an excellent opportunity to make an impact in the pharmaceutical and oncology space.

We’re seeking a US Regulatory Affairs Lead to support regulatory strategy, submission activities, and cross-functional collaboration for innovative pharmaceutical programs.

Position: US Regulatory Affairs Lead

Contract Duration: 6 months, with potential extension

Schedule: Monday–Friday, 40 hours per week

Travel: Little to no travel expected

Key Responsibilities

• Support US regulatory strategy and execution for new products and indication expansions.
• Prepare and contribute to FDA meeting materials, regulatory research, and regulatory intelligence.
• Lead or support IND, NDA, and BLA submissions to the US FDA.
• Collaborate with Clinical, Global Regulatory, and other cross-functional teams.
• Develop and coordinate regulatory submission processes and documentation.
• Support regulatory assessments of external innovation opportunities.

Required Qualifications

• Bachelor’s degree in a relevant scientific discipline; advanced degree preferred.
• 7–10+ years of Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
• Strong knowledge of US FDA regulatory requirements and submission procedures.
• Hands‑on experience with IND, NDA, and/or BLA submissions.
• Strong communication, project management, and cross-functional collaboration skills.

Who Should Apply?

Experienced US Regulatory Affairs professionals with a background in drug development, FDA submissions, regulatory strategy, and pharmaceutical product lifecycle management.