CMC Liaison - Pain - Global Regulatory Affairs

Job Description Job Purpose: As the single point of contact for all RA CMC related activities for the alocated therapeutic category/ies, leads a GRA CMC sub team to deliver the necessary advices and to provide the registration documents for new submission, accreditation, geographical expansion and maintenance activities (MAs variations and renewals) according to Category global regulatory strategies.

Major Accountabilities: • Member of GRT for the allocated Category/ies. • Manages all regulatory interactions between Global Regulatory Affairs Categories (GRA) and the GRA CMC organization for the allocated category/ies. • Ensures high quality level liaison with HAs either directly with FDA or through regional/ local organizations with other agencies for advisory meetings or any other technical contacts to defend submission strategy or challenge file evaluation outcomes. • Accountable to deliver high quality registration / accreditation documents according to plans and organization needs for maintenance activities. • Establishes RA CMC strategy and executes global/regional regulatory activities in collaboration with the Regional RA Liaisons (North America, Europe, SGM) in allocated therapeutic area/s. • Provides RA CMC advices and expertise to the GRA Category team and regional liaisons as needed in the evaluation of new opportunities and for development of products. Acts as the point of contact for TD team and implements necessary actions to maximise probability of approval for new dossier from a RA CMC view point (e.g. gap analysis? ). • Supports Due Diligence activities as required and delivers inputs for ER, DR and Scope changes (Ideal process)in terms of technical information, GRA CMC requirements and evaluation of resources needs. • Supports global and regional regulatory affairs associates for life-cycle maintenance of marketed products (renewal, variations) within teh alloacted Category/ies. • Interacts with Global Reg Ops in order to deliver high quality regions/countries specific documents for new registrations, variation and renewals. • Implements GRA CMC initiatives and ensures line management responsibilities for the RA CMC category team. Develops associates potential. • May contribute to special assigned activities and projects within the team and represent GRA in cross functional teams.

Challenges: • Organizes the Global PPY RA CMC sub-team communicates resources needs, follows budgets and allocates responsibilities. • Establishes working processes with supervisor and others RA liaisons within RA or outside • Proactively identifies, communiactes and addresses issues • Meets global/regional regulatory needs (new files, variations, renewal) within the allocated category/ies • Leverages experience across regions for the allocated projects/products and provides valid RA CMC advices on a global basis.

Please refer to job code 58388BR when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Trenton, NJ
County:	Mercer County
ZIP Code:	08601
Pay Rate:	Open
Job Terms:	full time
Company:	Sandoz Inc
Phone:	email only please
Fax:	email only please