Regulatory Affairs Consultant

Job Title: Regulatory Affairs Consultant

Location: Cambridge, Massachusetts (Hybrid)

Job Summary: We are seeking a seasoned professional to join our team, providing crucial regulatory CMC expertise and strategic support for global pharmaceutical development and operations. Our team relies on this position to ensure smooth submission processes, accurate documentation, and seamless coordination between regulatory stakeholders and affiliates.

Responsibilities

• Deliver strategic and operational regulatory CMC expertise and support for cross-functional teams, driving business objectives.
• Prepare and compile regulatory submissions and operational plans for assigned projects, ensuring concise and accurate delivery to health authorities.
• Write and review global and regional CMC submission documents and responses, managing health authority interactions and negotiation of approvals as needed.
• Coordinate regulatory assessments of CMC changes, maintain records, and support risk assessment and mitigation in alignment with global strategy.
  
  

Required

• Minimum 3-5 years relevant experience in the pharmaceutical industry or regulatory authority CMC review capacity, including at least 3 years in regulatory CMC.
• Professional experience (preferably 2 years) in pharmaceutical manufacturing, analytical development, quality assurance/control, or related technical field.
• Proven authoring and contribution to CMC submission documents for development and/or marketed pharmaceutical products (biological, oligonucleotide, and/or chemical entities).
• Experience in leading cross-functional teams, operating within a matrix organizational structure, and managing projects across global locations/time zones.
  
  

About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

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