Regulatory Affairs Specialist V-41593

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

Growing Pharmaceutical, Biotechnology and Medical Device companies always need TOP Talent. Since 1996, MakroScientific’s proven staffing solutions have helped many Life Sciences companies succeed and visualize their goals by increasing innovation and decreasing costs while maintaining the complex service level expectations.

Our global presence with offices in USA (NJ, PA, IL, CA) and offices in UK, Europe and Asia enables us to be a powerful contributor and connector of right Talent.

Job Description

• This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual updates, NDA annual reports, PBRERs).
• With oversight and guidance, contributes to the generation of product regulatory strategy documents (for products in phase 1-3 clinical development), labeling updates for marketed products, generation of FDA meeting requests and corresponding briefing materials, and other tasks as needed.

Qualifications

• Working knowledge of FDA and ICH requirements for standard regulatory documents and their maintenance.
• Excellent written and verbal communication skills, with ability to organize and manage multiple priorities.
• Proficiency in MS Word, Excel, and PowerPoint.
• Self‑starter with the ability to work independently but seeking out guidance as needed.
• Technical aptitude to work across multiple information systems and databases with ability to troubleshoot.
• Sense of urgency and perseverance to achieve results.

Education

• Bachelor’s degree and at least 5 years in Regulatory Affairs or relevant industry experience, or
• Master’s, PharmD, PhD degree and 3 years in Regulatory Affairs or relevant industry experience.

Additional Information

Need someone that has worked on a regulatory team, preparing regulatory documents. Candidates will need to understand the content; really looking at regulatory strategy and drug development and synthesizing that information for reports.