Reference Number: JO-2001-443571
Global CMC Senior Regulatory Affairs Associate
Job Type: Permanent
Role: Global CMC Senior Regulatory Affairs Associate
Location: Cambridge 2 days home working flexibility
Employment: permeant, full time
Reference number: JO-2001-443568
Our client is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need; their therapeutic areas of focus include HIV/AIDS, liver diseases, cancer, inflammation, cell therapy, and serious respiratory and cardiovascular conditions.
Prepare the sections of INDs/IMPDs, new MAAs, CMC variations and renewals for submission in Rest of World (RoW) territories. Ensure that dossiers meet ICH and local regulatory requirements.
Manage the preparation of responses to CMC questions from regulatory authorities.
Work with pharmaceutical development, manufacturing, QA and external partners to deliver CMC Quality components for regulatory submissions in ROW territories in accordance with corporate objectives or post-licensing commitments.
Liaise with our clients local Affiliates, distributors or agents to define/clarify CMC submission requirements.
Provide advice to pharmaceutical development and manufacturing colleagues on RoW regulatory requirements for new submissions and for post approval change management.
Assess the regulatory impact of changes to assigned clinical and commercial products
Develop expertise in assigned product areas and become Subject Matter Expert (SME) for assigned CMC Regulatory activities
Knowledge, Experience & Skills:
Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.
Experience in the preparation and maintenance of CMC components of regulatory submissions.
Excellent organization skills and ability to work on a number of projects with tight timelines.
Excellent verbal and written communication skills and interpersonal skills.
If you are interested in discussing this role further then please email your CV to email@example.com or call Amani on 01189 522 797 to arrange a confidential discussion.
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.