Senior Regulatory Affairs Associate – Biologic CMC
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
- UG: Bachelor’s degree in a relevant field
- PG: Master’s degree in Regulatory Affairs or a related field is preferred
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.