CMC Regulatory Affairs Associate | Drive Global Submissions

Parexel; Medellín; On-site; COP 143,646,000 - 207,489,000; Full time

Job summary

Parexel is seeking a Senior Regulatory Associate to author global CMC variation submissions, annual reports, renewals, and post-approval roll-outs. You will prepare CMC packages, manage change controls, and ensure regulatory compliance across regions.

Ideal candidates have 5+ years in biotech/pharma regulatory affairs, with M3 authoring experience and proficiency in coordinating submissions with LRAs and clients. Strong writing and stakeholder skills are essential.

Qualifications

• Minimum of 5 years’ experience in biotech/pharmaceutical industry.
• At least 5 years in Regulatory Affairs CMC for Senior level; 2 years for Associate level.
• Experience with biological products and vaccines preferable; M3 authoring experience mandatory.
• Strong regulatory writing skills and ability to evaluate CMC information for compliance.
• Knowledge of regulatory frameworks in multiple regions (US, EU, Japan, etc.).

Responsibilities

• Author CMC variations submissions, annual reports, renewals, and post-approval roll-outs.
• Prepare and review CMC packages and submissions; manage change control assessments.
• Coordinate submissions planning, binders, and content plans; support eCTD sequencing reviews.
• Act as main GRA point of contact for LRAs and stakeholders.
• Ensure compliance with client SOPs and participate in team communication.

Skills

Regulatory experience

CMC writing

Stakeholder mgmt

Time management

Team collaboration

Veeva experience

Education

BS/BA/MS in biological sciences

Regulatory Affairs degree (advantageous)

Tools

Veeva

Job description

Parexel is seeking a Senior Regulatory Associate to author global CMC variation submissions, annual reports, renewals, and post-approval roll-outs. You will prepare CMC packages, manage change controls, and ensure regulatory compliance across regions.

Ideal candidates have 5+ years in biotech/pharma regulatory affairs, with M3 authoring experience and proficiency in coordinating submissions with LRAs and clients. Strong writing and stakeholder skills are essential.