Senior Regulatory Affairs Manager - West London Contract

Key People

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Job ID :

8851


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--West London,West London,


Key Skills :

regulatory affairs, clinical trial applications, CTA, EMEA, PIP, MAA, Post Approval


Salary :

£55 - £62 per hour


Date Posted :

26 Sep, 2017



Company Name :

Key People


Location1 :

West London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Within this role you will provide regional regulatory support for one or more products, and as a member of the Global Regulatory Team (GRT), will be accountable for developing and executing regional regulatory strategies across the product lifecycle and managing effective agency interactions.

You will have a strong background supporting the diversity of regulatory procedures in the EU (inc. PIPs, variations, IMPDs, MAAs) and ability to work autonomously. The purpose of this role is to progress the client pipeline through timely regulatory approvals, including clinical trials for investigational medicinal products, as well as approved medicinal products, and to ensure timely regulatory compliance with such approvals.

Responsibilities:
- Define and advise the GRT on regional considerations in developing creative regulatory strategy
- Ensures European regional needs are well defined and implemented in collaboration with relevant regional stakeholders
- Develops and implements regulatory strategy and executional plans, and manages regulatory submissions (e.g. clinical trial and marketing applications) for assigned products in accordance with global filing plans, core labelling documents and regulatory requirements
- Leads development of regional regulatory documents and meetings, and provides regulatory advice on regional regulatory requirements, mechanisms to optimize product development and to maintain compliance
- Co-ordinates and provides guidance to company responses to requests from regulatory authorities, e.g Response to Questions (RTQs)
- Communicates and ensures alignment with proposed regulatory strategies such that expectations, regulatory risks and mitigations are characterised and understood.
- Estimate the likelihood of regulatory success and timelines based on proposed strategies; discuss with GRT and line Management, and communicates to stakeholders
- Maintains an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to company products, and evaluates and communicates impact
- Act as contact and create relationships with agency staff on specific product assignment and document and communicate details and outcomes of regulatory agency interactions

Basic Requirements:
- Demonstrable experience acting as therapeutic area European Regulatory Affairs lead, defining and implement regulatory strategies and executional plans
- Practical Regulatory knowledge of regional legislation
- Working with policies, procedures and SOPs
- Experience with national legislation and regulations relating to medicinal products
- Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals
- Understanding of drug development
- Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
- Comprehensive understanding of regulatory activities, touch points and how they affect projects and processes
- Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
- Cultural awareness and sensitivity to achieve results across both regional country and International borders

Preferred Requirements:

- Experience in oncology therapeutic area
- Experience working with biotechnology products

Please contact Tim Barratt for further details.


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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