Parexel Regulatory Affairs Job Vacancies – Senior Regulatory Affairs Associate
Are you an experienced professional in Regulatory Affairs within the field of Biologic CMC? Here’s an exciting opportunity to join Parexel as a Senior Regulatory Affairs Associate based in Bengaluru, India.
About the Role
Job Title: Senior Regulatory Affairs Associate
Location: Bengaluru, India
Job ID: R0000003109
Category: Regulatory / Consulting
Role Responsibilities
As a Senior Regulatory Affairs Associate, you will be a crucial part of Parexel’s Regulatory Affairs team. Your responsibilities include:
- Supporting CMC activities related to Vaccine/Biologic manufacturing and control.
- Authoring submission dossiers for new applications and post-approval variations.
- Demonstrating a comprehensive understanding of EU/CA/WHO/US regulations and guidance, ensuring compliance in data review and compilation.
- Managing CTD updates and authoring, specifically in CTD Modules 1, 2 & 3.
- Handling Health Authorities Requests and responding effectively.
- Managing US & CA Annual reports, Renewals, PQVAR, and APR.
- Assessing Change Controls and associated technical dossiers.
- Exhibiting exceptional project management and communication skills.
- Utilizing Veeva tool experience for streamlined operations.
Qualifications and Experience
- Minimum of 5+ years of experience in Biologic CMC regulatory affairs.
- Education: Bachelors/Masters in Pharmacy OR Bachelors/Masters in any of the Life Sciences fields.
- Proven experience in authoring submission dossiers, specifically for new applications and post-approval variations.
- Strong understanding of EU/CA/WHO/US regulations and guidance.
- Proficiency in CTD updates/authoring (CTD Modules 1, 2 & 3).
- Experience in managing Health Authorities Requests and responses.
- Handling US & CA Annual reports, Renewals, PQVAR, and APR.
- Expertise in assessing Change Controls and technical dossiers.
- Excellent project management and communication skills.
- Proficient in using Veeva tools.
Join Our Team
At Parexel, we offer an inclusive and innovative work environment that values diversity and encourages professional growth. If you’re passionate about regulatory affairs within the Biologic CMC field, and you have the experience and expertise we’re looking for, we invite you to apply for the Senior Regulatory Affairs Associate position.
