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 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:

• 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 wave 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 (Client to assess major impact countries, vendor to assess impact for all other countries).

• Confirm CMC requirements for submission e.g. variation, renewal, tender, etc.

• Align with the client (information flow to be defined) on technical information to be provided and timelines.

• Preparation of the CMC packages.

• Provide packages for internal client review and update these as needed.

• Provide finalized packages for publishing and QC published output.

• 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 impact countries.

Education:

• University degree in biological sciences or related 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.

• Sound knowledge in natural sciences with a focus on biological/vaccines/small molecule medicinal products.

• Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia).

• Strong regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements.

• Knowledge in Good Manufacturing Practice or related areas would be highly regarded.