Senior Regulatory Consultant

Key People


Job ID :

12372


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Buckinghamshire,Buckinghamshire,


Key Skills :

regulatory, regulatory affairs, CTA, MAA, post approval, variations, renewals, contract, consultant,


Salary :

£60 - £70 per hour


Date Posted :

27 Jul, 2018



Company Name :

Key People


Location1 :

Buckinghamshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

I am currently recruiting for an experienced Regulatory Consultant to join a Top 10 Pharma client based in Buckinghamshire on an initial 12 month contract basis. The ideal candidate will have a strong full life cycle background with experience ranging from development through to registrations and Post Approval activities.

Responsibilities:

*Input in development, post-approval and life cycle management
*Participate in global regulatory team meetings as appropriate;
*Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned;
*Develop an understanding of the regional regulatory environment, competitor intelligence and therapeutic area.

Liaison with Regulatory Agencies and Local Operating Companies:

*Act as back-up for contact with Regulatory Agencies as needed;
*Draft cover letters for Regulatory Agency communication;
*Assist in the preparation of meetings with Regulatory Agencies;
*Liaise with LOCs, track and respond to queries in a timely manner.
Input in document and process development:
*Assist in development of processes related to regulatory submissions;
*Draft and review some document content (depending on level of regulatory knowledge/expertise)
*Provide input to documentation to ensure they thoroughly and accurately answer the questions being posed;
*Track dates of submissions and Regulatory Agency responses.

Clinical Trial Applications (CTA):

*Review protocols and ensure alignment with regulatory requirements;
*Advise team on required documents and submission strategies in preparation of CTAs;
*Ensure CTA submission packages are complete and available according to agreed timelines;
*Review and approve clinical trial supply plans.
Marketing Authorization Applications (MAA)
*Provide regulatory support throughout registration process and life-cycle management;
*Advise team in required documents and submission strategies in preparation of MAA as assigned (in collaboration with LOCs as appropriate)
*Assist with timely MAA availability, ensure that all document components are in place on time, identify and track critical path activities;
*Assist with submission and acceptance of MAA;
*Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.

For further details, please contact Tim Barratt on +44(0)1727 817 626 or email 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.

View all Key People Jobs



© 2018 Jobsinpharma - 4ward Technologies Ltd All rights reserved.