Senior Regulatory Associate, CMC

Key People

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Job ID :

9311


Company Type :

Staffing Firms


Industry :

Science and Research


Education Level :

Bsc


Address 1 :

United Kingdom,London,London,


Key Skills :

cmc, regulatory, associate, senior associate, london, cambridge


Salary :

£25 - £35 per hour


Date Posted :

31 Oct, 2017



Company Name :

Key People


Location1 :

London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Within this role you will assist with, under the direction of a Regional Regulatory Lead, the creation and submission of regulatory documents and you may be the regulatory lead for a program under the supervision of a more experienced regulatory lead!

Responsibilities:

-Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing, regulatory authority meeting preparations)
-Provide and maintain CMC, CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
-Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications
-Review regional component of the Global Regulatory Plan and provide input to operational deliverables
-Ensure compliance via timely submissions to regulatory agencies
-Support RRL in review of promotional materials for commercial activities (ex-US)
-Collaborate with CROs / partners to support site initiation
-Coordinate collection of functional documents in support of regulatory applications
-As appropriate participate in GRT to support execution of regulatory strategy
-Coordinate QC of regulatory documentation (e.g. briefing packages)
-Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages)
-Prepare regulatory packages and cross-reference letters to support investigator initiated studies
-Approve drug shipment for the company and Investigator Initiated Studies
-Complete regulatory forms to support agency communications (E.G. EudraCT,)
-Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
-Support process improvement initiatives, standards development, and metrics
-Assist in template development and maintenance
-Respond to specific requests from and communicate relevant issues to GRT
-Develop Regulatory Position with teams
-Actively support regulatory compliance
-Support the development and execution of GRT goals

Key Skills

-Strong communication skills - oral and written
- Ideally a CMC background
- EU and Emerging Markets exposure.
-Organizational skills
-Understanding of drug development process

For further details, please contact Tim Barratt on +441727 817 626 or email 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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