Cmc Regulatory Affairs Associate (M3 Authoring Experience For Biological Products )

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

When our values align, there's no limit to what we can achieve.

Join Our Growing Team of CMC Regulatory Professionals!

The Senior Regulatory Associate will author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests. Responsibilities include preparing and reviewing CMC packages, supporting GMP submissions, managing change control assessments, and ensuring compliance with regulatory requirements across multiple regions. The role requires strong technical regulatory expertise, excellent writing skills, and the ability to evaluate scientific CMC information for accuracy. A degree in biological or health sciences (Regulatory Affairs preferred) and at least 5 years of experience in CMC regulatory affairs within the biotech or pharmaceutical industry are essential.

Activities:

• 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 (i.e. planning, submission package compilation, RtQ preparation, Spontaneous HA queries, etc.);
• General submission coordination: Submissions planning (tracker update, timelines agreement with LRA and GRA-CMC, recurrent meetings with LRAs), create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences;
• Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
• Excellent communication and stakeholder management skills;
• Strong organizational and time management skills;
• Strong problem-solving skills;
• Coordinate all assigned activities;
• Ensure compliance to all client SOPs/training sessions;
• Proactive’ and ‘efficient' work ethic; Strong oral skills, with proven ability to work efficiently as part of a team;
• Strong interpersonal skills.

Education:

University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD), a degree in Regulatory Affairs is advantageous.

Experience:

• Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC for Senior and 2 for Associate level
• Experience with biological products - Mandatory - and Vaccines preferable)
• M3 authoring experience - mandatory
• Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia).
• Regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements - nice to have
• Knowledge in Good Manufacturing Practice or related areas would be highly regarded.
• Experience using Veeva

This role offer exciting opportunities for growth and impact within a collaborative and forward-thinking team environment. Ideal candidates will be motivated by the chance to shape regulatory strategies, drive successful submissions, and ultimately contribute to bringing important medical advancements to patients worldwide.