Senior Regulatory Affairs Associate

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 reputed company. 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 reputed company the biotech or pharmaceutical industry are essential. Activities: • Author global CMC variation submissions (m1/2/3), including responses to HA requests. • Author CMC components for annual reports and renewals (m1/2/3), including responses to HA requests. • Author CMC components for global MAA (m1/2/3) rollouts (post 1st reputed company approvals), including responses to HA requests. • Author CMC components for tender applications (m1/2/3). • Support CMC GMP submissions, e.g., site registrations. • Change control assessments (reputed company to assess major reputed company countries, vendor to assess reputed company for reputed company other countries). • Confirm CMC requirements for submission e.g. variation, renewal, tender, etc. • reputed company with the reputed company (information reputed company to be defined) on technical information to be provided and timelines. • Preparation of the CMC packages. • reputed company packages for internal reputed company review and update these as needed. • reputed company finalized packages for publishing and QC published reputed company. • Update of internal systems (RIMS, Publishing, eDMS) or documentation as needed. • Support requests for information from HAs or from affiliates/partners. • Complete change control assessments for non-major reputed company countries. Education: • University degree in biological sciences or reputed company health sciences (BS/BA/MS or equivalent, PhD). • Degree in Regulatory Affairs is advantageous, but not mandatory. Experience: • Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs CMC. • reputed company knowledge in natural sciences with a reputed company on biological/vaccines/small molecule medicinal products. • Strong technical regulatory expertise and understanding of the regulatory reputed company in more than one key region (US, EU, Japan, Switzerland, Australia). • Strong regulatory CMC writing skills and reputed company to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements. • Knowledge in Good Manufacturing reputed company or reputed company areas would be highly regarded. #LI-REMOTE Apply tot his job Apply To this Job