Regulatory Consultant, CMC

Key People


Job ID :

15424


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,London,London,


Key Skills :

cmc, manager, consultant, contract, consultant, biologics


Salary :

£50 - £70 per hour


Date Posted :

04 Nov, 2019



Company Name :

Key People


Location1 :

London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for an experienced CMC specialist to join a CRO on an initial 6-12 month contract basis. Excellent rates and 100% home working are on offer! Previous biologics experience is ESSENTIAL for this role.

Responsibilities:
*Accountable for file-ability and approvability of CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval
*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.
*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
*Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.

Experience Required:
*A minimum of a graduate degree in Life Sciences
*Candidates with experience in pre and post approval biologics CMC, including for monoclonal antibodies, insulin products regulatory filings.
*Biosimilar experience would be an advantage
*Significant knowledge on Biologics regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
*Significant knowledge of ICH guidelines and BLA submission requirements of various markets such as USFDA, EMA etc.

For further details, please contact Tim Barratt on 01727 817626 or send a copy of your CV to tbarratt@keypeople.co.uk


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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