Senior Regulatory Affairs Associate – Biologic CMC | Bengaluru

Senior Regulatory Affairs Associate – Biologic CMC

Introduction:

Are you a skilled Regulatory Affairs professional with a background in Biologic CMC? If you’re looking for a rewarding opportunity, we invite you to explore the role of Senior Regulatory Affairs Associate at our organization. Join us in Bengaluru, India, and be part of a dynamic team working on critical projects in the biologics field.

Vacancies List: We are currently seeking a Senior Regulatory Affairs Associate for our Biologic CMC team.

Position Title: Senior Regulatory Affairs Associate – Biologic CMC

Company Name: Parexel

Salary: Competitive, commensurate with experience

Company Address: 3rd Floor, Campus 5B, RMZ Ecoworld SEZ Sarjapur Marthahalli Road, Village, Devarabisanahalli, Bengaluru, Karnataka 560103

Detailed Job Description:

Role: Senior Regulatory Affairs Associate

Industry Type: Regulatory / Consulting

Department: Biologic CMC

Employment Type: Full-Time

Role Category: Regulatory Affairs

Education:

• UG: Bachelor’s degree in a relevant field
• PG: Master’s degree in Regulatory Affairs or a related field is preferred

Key Skills:

In this role, you will need to demonstrate the following skills and qualifications:

• 4 to 7 years of experience in Regulatory Affairs, specifically in the Biologic CMC domain.
• Proficiency in supporting CMC activities related to Vaccine, Biologic, and Small Molecules manufacturing and control.
• Authoring submission dossiers for new applications and post-approval variations.
• Deep understanding of EU/CA/WHO/US regulations and guidance for compiling data to meet appropriate standards and requirements.
• Experience in CTD update/authoring, including CTD Module 1, 2&3.
• Handling and responding to Health Authorities Requests.
• Preparation of US & CA Annual reports, Renewals, PQVAR, and APR.
• Assessment of Change Controls and associated technical dossiers.
• Exceptional project management and communication skills.
• Proficiency with Veeva regulatory tools.