Remote CMC Regulatory Affairs Associate — Submissions

Parexel; México; Remote; MXN 600,000 - 1,200,000; Full time

Job summary

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 CMC packages, support GMP submissions, manage change control assessments, and ensure regulatory compliance across regions.

Ideal candidates have at least 5 years in biotech/pharma regulatory affairs, strong M3 authoring experience, and solid cross-regional regulatory knowledge. Remote work options are available.

Qualifications

• Minimum 5 years in biotech or pharmaceutical regulatory affairs.
• Experience in Regulatory CMC for Senior and Associate levels.
• Experience with biological products and vaccines preferable.
• M3 authoring experience mandatory.
• Strong regulatory CMC writing skills across multiple regions (US, EU, Japan, etc.).
• Knowledge of GMP or related areas is valued.
• Experience using Veeva is required.

Responsibilities

• Conduct and deliver high quality, on time CMC regulatory activities, including compliant management of all internal tools and client systems;
• Author Administrative and CMC regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to prepare submission packages;
• Full management of CMC submissions (planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.);
• General submission coordination: Submissions planning (tracker updates, timelines with LRAs/GRA-CMC, meetings), create submission binders and Content Plans, coordinate publishing, review eCTD sequences;
• Act as main GRA point of contact for LRAs and other stakeholders for queries;
• Excellent communication and stakeholder management skills;
• Strong organizational and time management skills;
• Coordinate all assigned activities; ensure compliance to SOPs/training;
• Proactive and efficient work ethic; Strong oral skills, and team collaboration;
• Strong interpersonal skills.

Skills

Regulatory CMC

Technical writing

Stakeholder management

Project coordination

Time management

Communication skills

Problem solving

Team collaboration

Education

Biological sciences degree

Regulatory Affairs qualification

Tools

Veeva

Job description

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 CMC packages, support GMP submissions, manage change control assessments, and ensure regulatory compliance across regions.

Ideal candidates have at least 5 years in biotech/pharma regulatory affairs, strong M3 authoring experience, and solid cross-regional regulatory knowledge. Remote work options are available.