Senior Regulatory Affairs Product Lead – Specialty Generics

LanceSoft Inc; Hazelwood (MO); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is looking for a Sr. Regulatory Affairs Product Specialist to develop and implement regulatory strategies for drug products. This role involves managing regulatory submissions, ensuring compliance, and communicating with regulatory authorities. The ideal candidate has a Bachelor's degree in a scientific discipline, at least 5 years of experience in the Pharmaceutical Industry, and strong skills in regulatory processes. Excellent interpersonal and organizational skills are required.

Qualifications

• Minimum 5 years of experience in the Pharmaceutical Industry.
• Hands-on experience leading various Regulatory submission activities.
• Familiar with regulatory concepts and practices.

Responsibilities

• Serve as Regulatory representative on cross-functional teams.
• Perform regulatory assessments on proposed change controls.
• Manage and publish regulatory submissions using eCTD software.

Skills

Regulatory submission activities

Interpret Regulatory Authority policies

Project risk assessment

Attention to detail

Strong interpersonal skills

Education

Bachelor’s degree in Chemistry, Biology, Pharmacy or related field

Graduate degree preferred

Tools

Trackwise

Job description

A leading pharmaceutical company is looking for a Sr. Regulatory Affairs Product Specialist to develop and implement regulatory strategies for drug products. This role involves managing regulatory submissions, ensuring compliance, and communicating with regulatory authorities. The ideal candidate has a Bachelor's degree in a scientific discipline, at least 5 years of experience in the Pharmaceutical Industry, and strong skills in regulatory processes. Excellent interpersonal and organizational skills are required.