For the assigned products/programs, define and execute an RA-CMC Strategy that best serves the biosimilars business needs and ensure compliance with regulatory systems.
Manage: Change Controls evaluation; The preparation and finalization of Quality regulatory documents which form the basis of worldwide submissions for clinical trials (IND/IMPDs), initial marketing authorization applications (MAA/BLA M3) and LCM activities like manufacturing site transfers. This includes the preparation and compilation of M3 sections and other CMC related dossier elements (e.g. QOS, M1 CMC elements) in collaboration with internal and external subject matter experts; Planning and coordination of CMC related submissions with regulatory functions; Track approval and provide regulatory input for changes implementation strategy in close collaboration with Quality, Supply and CMC functions.
As Business partner to the Biosimilar CMC team and Regulatory Teams, represent the RA-CMC team in cross-functional forums.
Represent and defend the Company strategy in front of Health Authorities: Respond to HAs questions in line with the Company CMC strategy; Elaborate responses in close collaboration with CMC teams and site representatives in a timely manner; Create comprehensive story lines for submissions; Participate to HAs meetings and present the RA-CMC submissions content to assessors, seeking endorsement of the Company strategy.
Manage externalization of RA-CMC activities as required.
Ensure regulatory CMC requirements are met along the assigned project development work.
Keep up to date with the latest regulatory CMC requirements through regulatory surveillance. Coordinate timely implementation of any changes or new relevant laws or guidance; provide comments on new laws on behalf of FK-SBS through the appropriate procedure, as applicable.
Serve as an interface between company functions as appropriate.
Manage distribution of RA-CMC activities within sub-team, external and internal partners as required.
Prepare briefing books and provide support at Regulatory agencies meetings on CMC aspects.
Ensure that the input in quality development incorporates the outcome of consultations and negotiations with Regulatory Authorities.
Carry out regulatory review of study / technology transfers protocols and reports used as CMC source documentation for the regulatory sections authoring. Liaise with authors and data generating functions as applicable.
Ensure regulatory filing systems are maintained and up to date.
Lead CMC Regulatory task forces on assigned projects.
Minimum Masters Degree in a Life Science or related discipline.
Between 5-8 years Regulatory Affairs CMC experience in a Biotech environment.
Experience with biological products, preferably Monoclonal antibodies (mAb).
Experience in managing international regulatory submissions, BLA/MAA and LCM variations.
Experience in managing DS and DP site transfers.
Experience in interaction with regulatory agencies.
Excellent spoken and written English. A second major language would be an advantage.
Excellent written and spoken communication skills.
Excellent interpersonal skills.
Good organizational and planning skills
Attention to details.
Ability to work in teams.