Global CMC Regulatory Associate - Submissions & Strategy

Parexel; United States; Remoto; USD 120.000 - 160.000; Tempo pieno

Descrizione del lavoro

Parexel is seeking a Senior Regulatory Associate to author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs. You will prepare and review CMC packages, support GMP submissions, manage change control, and ensure regulatory compliance across multiple regions with strong writing and project-management skills.

The role requires a degree in biological sciences, 5+ years in biotech/pharma regulatory affairs, and experience with biological products and

Competenze

• University degree in biological sciences or related health sciences; Regulatory Affairs degree advantageous.
• Minimum 5 years in biotech/pharma with 5+ years Regulatory Affairs CMC for senior and 2+ years for associate level.
• Experience with biological products – mandatory; vaccines preferable.
• M3 authoring experience mandatory.
• Strong regulatory expertise across US, EU, Japan, Switzerland, Australia.
• Knowledge of GMP or related areas is highly regarded.
• Experience using Veeva.

Mansioni

• Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs across regions.
• Prepare and review CMC packages and support GMP submissions.
• Manage change control assessments and ensure regulatory compliance.
• Coordinate submissions: planning, tracker updates, timelines, and binders; review eCTD sequences.
• Serve as main GRA point of contact for LRAs and stakeholders; respond to queries.
• Demonstrate excellent communication, stakeholder management, organization, and timely delivery.
• Work in a collaborative team environment to shape regulatory strategies and successful submissions.

Conoscenze

Regulatory writing

Regulatory affairs knowledge

Stakeholder management

Communication skills

Time management

Problem-solving

Team coordination

Veeva experience

Formazione

BS/BA/MS in Biological Sciences

Regulatory Affairs degree advantageous

Strumenti

Veeva

Descrizione del lavoro

Parexel is seeking a Senior Regulatory Associate to author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs. You will prepare and review CMC packages, support GMP submissions, manage change control, and ensure regulatory compliance across multiple regions with strong writing and project-management skills.

The role requires a degree in biological sciences, 5+ years in biotech/pharma regulatory affairs, and experience with biological products and