CMC Biologics Manager

Location
Homeworking
Salary
£45.00 - £65.00 per hour
Posted
18 Jul 2019
Closes
15 Aug 2019
Ref
24423
Contact
Ross Wilson
Discipline
Regulatory Affairs, CMC
Hours
Full Time
Contract Type
Contract
Experience Level
Management
My client, a CRO, is looking for a CMC Manager on a 6-12 months contract. This will be a home based role.

4Responsibilities
*Accountable for file-ability and approvability of CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval:
oNew applications for biological products including for monoclonal antibodies, insulin products
oLicense Maintenance of biological products: post authorization Changes, recurrent filings: annual reports, renewals
oResponses to Questions
oPost-Marketing Commitments (PMCs) , Follow-up Measures (FUM) and Other Regulatory Commitments
*Develop global Regulatory CMC strategies for client's biologics products to facilitate overall program goals.
*Provide regulatory CMC expertise on cross-functional project teams working with suppliers and contract manufacturers as required in order to ensure alignment of development and implementation of activities with overall regulatory CMC strategies.
*Develop and maintain positive working relationships with internal and external partners to facilitate efficient accomplishment of regulatory goals.
*Actively manage complex CMC regulatory submissions and ensuring quality and timelines are met for all pre and post approval biologics submissions.
*Manage regulatory CMC aspects of post approval change controls, liaising with stakeholders to ensure regulatory compliance. Responsible for recommending the appropriate regulatory reporting mechanism, in liaison with regional regulatory experts.
*Lead the preparation of CMC aspects of documents for regulatory agency interactions and may represent Regulatory CMC in agency meetings.
*Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
*Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance for biologics, and provide regulatory advice to project teams
*Reviews and resolves issues relating to project delivery or escalates appropriately to the Team Leader/ Program Leader/Program Director as required.
*Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.
*Identifies and provides standards for gathering information for use in trend analysis and reports information to company management.
*Have an ability to navigate through sensitive discussions with colleagues and clients providing effective positive/negative feedback
*May be a main point of contact for clients, maintaining interactions on a regular basis to understand the client's requirement for a particular project and ensure that the team meets or exceeds the targets in terms of quality, quantity within the scope of time constraints.
*Communicates effectively with internal clients to identify needs and evaluate alternative business solutions
*Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
*Maintenance of individual training records (Kinapse or client related) and completion of all designated required training