Global Regulatory Submissions Specialist

Net2Source (N2S); San Diego (CA); On-site; USD 44,083 - 48,216; Full time

Job summary

A leading staffing solutions provider based in San Diego is looking for a Regulatory Affairs Associate. This role involves providing regulatory support for US and global submissions, ensuring full compliance with documentation. Candidates should have a Bachelor's degree and at least two years of experience in Regulatory Affairs within the Medical Products Industry. Strong understanding of FDA, EU regulations and communications skills are crucial. Competitive hourly pay is offered for a contract duration of 12 months, with potential for extension.

Qualifications

• Minimum two years of experience in Medical Products Industry in Regulatory Affairs.
• Ability to assess scientific arguments loyally.
• Strong understanding of FDA, EU and global submission requirements.

Responsibilities

• Provide regulatory support and expertise for submissions.
• Prepare registration packages in line with regulatory requirements.
• Track completion of registration activities and ensure deadlines are met.

Skills

Understanding of FDA regulations

Regulatory submissions preparation

Problem-solving skills

Interpersonal skills

Communication skills

Negotiating skills

Education

Bachelor’s Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject

Job description

A leading staffing solutions provider based in San Diego is looking for a Regulatory Affairs Associate. This role involves providing regulatory support for US and global submissions, ensuring full compliance with documentation. Candidates should have a Bachelor's degree and at least two years of experience in Regulatory Affairs within the Medical Products Industry. Strong understanding of FDA, EU regulations and communications skills are crucial. Competitive hourly pay is offered for a contract duration of 12 months, with potential for extension.