Ophthalmology Global Regulatory Strategy Lead

Dennis Partners; Boston (MA); Hybrid; USD 130,000 - 180,000; Full time

Benefits offered by this job

Annual target bonus

Equity options

Comprehensive benefits package

Job summary

A leading biotechnology firm in Boston is seeking a Regulatory Strategy Manager to oversee global regulatory activities for investigational products. This role includes preparing regulatory submissions, guiding the team on responses, and supporting NDA submissions. Ideal candidates should possess a Bachelor’s degree in a scientific discipline with regulatory affairs experience. The firm offers excellent benefits and a collaborative culture, positioned at the forefront of innovation in retinal therapeutics.

Qualifications

• 4+ years of Regulatory Affairs experience for pharmaceutical drugs.
• Experience with preparation of INDs, amendments, and Briefing Books.
• Must have some experience responding to FDA queries.

Responsibilities

• Assist in implementing regulatory strategy plans for ophthalmology programs.
• Prepare regulatory submissions including INDs and NDAs.
• Review and proofreading regulatory documents for accuracy and completeness.

Skills

Regulatory writing

Communication skills

FDA requirements knowledge

MS Word proficiency

Adobe Acrobat Pro

Education

Bachelor degree in a scientific discipline

MS, PharmD, or PhD preferred

Tools

Regulatory Information Management Systems

eCTD templates

Job description

A leading biotechnology firm in Boston is seeking a Regulatory Strategy Manager to oversee global regulatory activities for investigational products. This role includes preparing regulatory submissions, guiding the team on responses, and supporting NDA submissions. Ideal candidates should possess a Bachelor’s degree in a scientific discipline with regulatory affairs experience. The firm offers excellent benefits and a collaborative culture, positioned at the forefront of innovation in retinal therapeutics.