Global Regulatory Affairs Specialist: Drug Development

Makro Scientific; Cambridge (MA); On-site; USD 80,000 - 110,000; Full time

Job summary

Makro Scientific is seeking an experienced professional to join their Global Regulatory Affairs team. The role involves planning, writing, and compiling regulatory reports such as DSURs and NDA annual reports, as well as contributing to product regulatory strategy documents.

The ideal candidate will have a Bachelor's degree and significant experience in Regulatory Affairs or a Master's/PhD with relevant expertise. Strong communication skills and proficiency in MS Office are essential.

Qualifications

• 5+ years of experience in Regulatory Affairs or relevant industry experience.
• Technical understanding of regulatory strategy and drug development.

Responsibilities

• Assist with planning, writing, and compiling regulatory reports.
• Contribute to product regulatory strategy documents.
• Generate FDA meeting requests and corresponding materials.

Skills

Working knowledge of FDA and ICH requirements

Excellent written and verbal communication skills

Proficiency in MS Word, Excel, and PowerPoint

Ability to work independently

Technical aptitude for information systems

Sense of urgency and perseverance

Education

Bachelor’s degree in relevant field with 5 years of experience

Master’s, PharmD, or PhD with 3 years of experience

Job description

Makro Scientific is seeking an experienced professional to join their Global Regulatory Affairs team. The role involves planning, writing, and compiling regulatory reports such as DSURs and NDA annual reports, as well as contributing to product regulatory strategy documents.

The ideal candidate will have a Bachelor's degree and significant experience in Regulatory Affairs or a Master's/PhD with relevant expertise. Strong communication skills and proficiency in MS Office are essential.