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, Rt Q 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 Integral Content List/Submission Content Plans, coordinate the publishing aspect, review of e CTD 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. Educ