CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products

This is a fully remote position, open to applicants in Mexico, +2 more countries.

📋 Description

• Execute and deliver high-quality, timely CMC regulatory activities, ensuring compliance in the management of internal tools and client systems.

• Draft administrative and CMC regulatory documents and deliverables.

• Work in collaboration with project SMEs and client stakeholders to prepare submission packages.

• Oversee CMC submissions, including planning, compilation of submission packages, preparation of responses to queries from Health Authorities, and RtQ preparation.

• Manage submission coordination by updating trackers, establishing timelines with LRAs and GRA-CMC, and participating in regular meetings with LRAs.

• Develop submission binders and Global Content Lists/Submission Content Plans.

• Oversee publishing activities and review eCTD sequences.

• Serve as the primary GRA contact for LRAs and other stakeholders.

• Organize all assigned activities.

• Ensure adherence to client SOPs and participate in training sessions.

• Contribute to regulatory strategies and successful submissions that advance medical developments.

⛳️ Requirements

• Bachelor's degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD).

• A degree in Regulatory Affairs is a plus.

• At least 5 years of experience in the biotech or pharmaceutical sector.

• Minimum of 5 years in Regulatory Affairs CMC for Senior level and 2 years for Associate level.

• Mandatory experience with biological products.

• Preferable experience with vaccines.

• M3 authoring experience is essential.

• Strong technical regulatory knowledge and comprehension of the regulatory framework across multiple key regions (US, EU, Japan, Switzerland, Australia).

• Proficient in regulatory CMC writing and capable of assessing technical and scientific CMC information for compliance and accuracy with applicable regulatory standards.

• Familiarity with Good Manufacturing Practice or related fields is highly valued.

• Experience with Veeva is advantageous.

• Exceptional communication and stakeholder management abilities.

• Strong organizational and time management capabilities.

• Excellent problem-solving skills.

• Strong oral and interpersonal communication skills.

• Proven track record of working effectively within a team.

• Ability to adhere to client SOPs and training requirements.

🏝️ Benefits

• Opportunities for personal growth and impact in a collaborative and innovative team environment.