Regulatory Affairs Manager

Key People


Job ID :

13597


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,South East,Uxbridge,


Key Skills :

regulatory, regulatory affairs, cta, development, contract, london


Salary :

£50 - £60 per hour


Date Posted :

21 Nov, 2018



Company Name :

Key People


Location1 :

Uxbridge




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Responsibilities:
Strategy and Execution
* Plans and manage regulatory submissions for products within the company portfolio in compliance with global filing plans and local regulatory requirements.
* Implement product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
* Provide content guidance for regional regulatory documents and meetings in accordance with global strategy
* Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use and paediatric plans)
* Supports regional label negotiation activities
* Participate in the development, and execution of regional regulatory product strategies
* Ensure regional needs are well defined and implemented in collaboration with relevant regional cross-functional stakeholders
* Communicates regulatory strategies within team

Basic qualifications:
* Scientific Degree and demonstrated experience in a similar role
* Regulatory principles
o Working with policies, procedures and SOP's
o Knowledge of legislation and regulations relating to medicinal products
o Awareness of the registration procedures in region for development, MA, post approval changes, extensions and renewals.
* Knowledge of drug development
* Knowledge of and experience in regional regulatory environment
* Team work
* Communication skills - both oral and written
* Ability to understand and communicate scientific/clinical information
* Ability to anticipate and prevent potential issues
* Ability to resolve conflicts and develop a course of action leading to a beneficial outcome

For further details about this role, or other opportunities within Regulatory Affairs, 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.

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