CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Prepare global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including addressing Health Authority inquiries.

• Develop and assess CMC packages while supporting GMP submissions.

• Oversee change control evaluations and ensure adherence to regulatory standards across various regions.

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

• Create Administrative and CMC regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to assemble submission packages.

• Manage all aspects of CMC submissions (e.g., planning, compilation of submission packages, RtQ preparation, addressing spontaneous HA queries, etc.).

• Handle general submission coordination, including planning submissions, assembling submission binders and Global Content List/Submission Content Plans, managing the publishing process, and reviewing eCTD sequences.

• Serve as the primary GRA contact for LRAs and other stakeholders, addressing any inquiries.

• Exhibit strong organizational and time management abilities.

• Coordinate all designated activities while ensuring compliance with all client SOPs and training sessions.

• Demonstrate strong problem-solving skills.

• Maintain a proactive and efficient work ethic.

• Possess strong verbal communication skills, with a proven ability to work effectively within a team.

• Showcase strong interpersonal skills.

⛳️ Requirements

• A university degree in biological sciences or a related health science field (BS/BA/MS or equivalent, PhD).

• A degree in Regulatory Affairs is a plus.

• A minimum of 5 years of experience in the biotech or pharmaceutical sector.

• At least 5 years in Regulatory Affairs CMC for Senior roles and 2 years for Associate roles.

• Experience with biological products and vaccines is essential.

• M3 authoring experience is required.

• Strong technical regulatory knowledge and understanding of the regulatory landscape in multiple key regions (US, EU, Japan, Switzerland, Australia).

• Regulatory CMC writing capabilities and the ability to assess technical and scientific CMC information for accuracy and compliance with relevant regulatory standards is a plus.

• Knowledge of Good Manufacturing Practice or related fields is highly valued.

🏝️ Benefits

• N/A