Author global CMC variation submissions, annual reports, renewals, and post-approval MAA roll-outs, including responses to Health Authority requests
Prepare and review CMC packages, support GMP submissions
Manage change control assessments and ensure compliance with regulatory requirements across multiple regions
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, RtQ preparation, Spontaneous HA queries, etc.)
General submission coordination: Submissions planning, create submission binders and Global Content List/Submission Content Plans, coordinate the publishing aspect, review of eCTD sequences
Act as main GRA point of contact for LRAs and other stakeholders (i.e. for responding to any queries)
Strong organizational and time management skills
Coordinate all assigned activities and ensure compliance to all client SOPs/training sessions
Strong problem-solving skills
Proactive and efficient work ethic
Strong oral skills, with proven ability to work efficiently as part of a team
Strong interpersonal skills.

University degree in biological sciences or related health sciences (BS/BA/MS or equivalent, PhD)
A degree in Regulatory Affairs is advantageous
Minimum of 5 years’ experience in the biotech or pharmaceutical industry
At least 5 years in Regulatory Affairs CMC for Senior and 2 for Associate
Experience with biological products and Vaccines
Mandatory
M3 authoring experience
mandatory
Strong technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, Switzerland, Australia)
Regulatory CMC writing skills and able to evaluate technical and scientific CMC information for accuracy and compliance with relevant regulatory requirements
nice to have
Knowledge in Good Manufacturing Practice or related areas would be highly regarded.

CMC Regulatory Affairs Associate, M3 Authoring Experience for Biological Products

Key skills