Senior Regulatory Associate

Key People


Job ID :

9505


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--Cambridge,Cambridge,


Key Skills :

pharmaceuticals, regulatory affairs, associate, officer, executive, scientific, science, CMC, variat


Salary :

Up to £25.00 per hour


Date Posted :

15 Nov, 2017



Company Name :

Key People


Location1 :

Cambridge




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. 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 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 CRO�s / 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 Amgen 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 Organizational skills Understanding of drug development process


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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