Regulatory Affairs Manager - Biotech Growth & Submissions

Damora Therapeutics; Massachusetts; On-site; USD 95,000 - 135,000; Full time

Job summary

Damora Therapeutics in Massachusetts is seeking a Manager/Senior Manager, Regulatory Affairs to drive key regulatory activities. This role involves supporting the timely submission and approval of regulatory submissions while managing cross-functional relationships.

The ideal candidate has 2-3 years of regulatory affairs experience in biotech or pharma, a Bachelor’s degree, and strong competency in global regulatory requirements. Join our team to help advance innovative treatments for hematologic disorders.

Qualifications

• 2-3 years of regulatory affairs experience in biotech or pharma.
• Experience supporting global regulatory submissions in US and ex-US regions.
• Strong competency in understanding global regulatory requirements.

Responsibilities

• Support timely submission and approval of regulatory submissions.
• Coordinate and prepare document packages for regulatory submissions.
• Manage cross-functional relationships with internal teams.

Skills

Regulatory affairs experience in biotech or pharma

Understanding of science and medicine

Cross-functional collaboration

Competency in global regulatory requirements

Education

Bachelor’s degree

Advanced degree (MS, PharmD, PhD)

Job description

Damora Therapeutics in Massachusetts is seeking a Manager/Senior Manager, Regulatory Affairs to drive key regulatory activities. This role involves supporting the timely submission and approval of regulatory submissions while managing cross-functional relationships.

The ideal candidate has 2-3 years of regulatory affairs experience in biotech or pharma, a Bachelor’s degree, and strong competency in global regulatory requirements. Join our team to help advance innovative treatments for hematologic disorders.