CMC Biologics Manager

Key People

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Job ID :

15130


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Kent,Kent,


Key Skills :

CMC, Biologics, Pre Approval, Post Approval, Monoclonal Antibodies, Insulin Products, Contract, Home


Salary :

£45.00 - £65.00 per hour


Date Posted :

19 Jul, 2019



Company Name :

Key People


Location1 :

Kent




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

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



Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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