Senior Regulatory Manager - Pharmaceuticals - 12-Month Contract

Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Regulatory Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness.

Responsibilities:

Responsible for the generation of country specific regulatory strategies and providing feedback to internal teams regarding submission plans and execution of the strategy for two or more products.
Interfaces with the affiliate offices for specific strategies or activities that impact a specific country.
Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC filings are considered and risks identified with appropriate contingency strategies
Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
Manages strategy and execution for all regulatory CMC submissions (e.g. late stage clinical trials, variations, extensions and marketing applications) for products within the portfolio in compliance with global filing plans and local regulatory requirements with minimal supervision.
Authoring and coordinating responses to questions across assigned products and countries.
Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
Provides guidance for regulatory assessments of change control request.
Sets project time frames and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
Gathering, consolidating and analysing regulatory intelligence for International Markets and supports its application to product-specific activities
Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
Maintain an awareness of new and developing legislation, regulatory policy and technical Regulatory guidance relating to the companies products.

If this role is of interest to you, please apply now!

#LI-KT1

We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.

Engineering Director
Global Pharmaceutical firm

We have worked together with QCS Staffing for seven years now and have always received a professional service. QCS Staffing's speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of QCS Staffing's people and their ability to deliver.

Engineering Director
Global Pharmaceutical firm

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Pharmacovigilance Associate

Salary

Competitive

Location

Leeds

Salary

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Sector

Drug Safety / Pharmacovigilance

Job type

Permanent

Location

England

Yorkshire

Description

Pharmacovigilance Associate - United Kingdom, Leeds - Permanent Contract Do you relish the opportunity to work with an international pharmaceutical organisation based in the UK? If yes, then

Reference

36947

Expiry Date

01/01/0001

Author

Kathryn Taylor

Author

Kathryn Taylor

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Senior Regulatory Manager

What is Pharmacovigilance (Drug Safety)?

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Senior Regulatory Manager

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What is Pharmacovigilance (Drug Safety)?

How has pharmacovigilance changed since the COVID-19 pandemic?

5 reasons you should work in drug safety and pharmacovigilance

Send us your CV