Regulatory Affairs Manager

Regulatory Affairs Manager Runcorn, England

Teva Pharmaceuticals
Full Time Runcorn, England 32708 - 47188 GBP ANNUAL Today
Job description

Regulatory Affairs Manager

Date: May 2, 2023
Location: Runcorn, United Kingdom, WA7 3FA
Company: Teva Pharmaceuticals
Job Id: 46467

Who We Are

We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us. We’re Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world and we currently have a fantastic opportunity for a Regulatory Affairs Manager to join our team on a full time, permanent basis in Runcorn.


At Teva Runcorn, we develop, manufacture and market innovative and affordable medicines, specialising in aseptically produced sterile liquid products mainly used for treating respiratory conditions using Blow-Fill-Seal technology as well as injectable Combination Products such as our Multiple Sclerosis treatment ‘Copaxone’.

A Day In the Life Of A Regulatory Affairs Manager

Provide Technical Leadership and Management of the Regulatory Team through coordination of resources for existing product submissions, site license maintenance and provision of regulatory compliance advice at the Teva Runcorn site.


Key Responsibilities:

  • Leadership of a small team of Regulatory Affairs professionals to devise tactics, complete submissions to project deadlines, provision of advice to on-site departments and act as liaison with market submission regulatory teams.

  • Resource Management to monitor and control central spend in line with agreed budget.

  • Project Management to plan, resource and coordinate the delivery of projects to support the achievement of product variations.

  • Coordination of meetings with global and regional teams to discuss strategies and resolve issues.

  • Interfaces with the site (R&D and Operations experts) to ensure regulatory strategies are integrated into site projects.

  • Support the preparation of regulatory filings.

  • Identification of issues and factors that may implicate a regulatory strategy or activity.

  • Responsible for the strategy and execution of the site specific aspects of the preparation of CMC amendments and post market supplements.

  • Recruit, develop and inspire members of the team to deliver a first-rate regulatory compliance service.

Who Are We Looking For?

Do you have?

  • A degree within Chemistry, Life Sciences or allied subject.

  • Extensive regulatory knowledge in pharma environments in the USA, EU and international markets.

  • Knowledge of cGMP regulatory requirements of pharma products processed using aseptic techniques.

  • A good understanding of the drug product life-cycle from product launch, maturation and supply cessation.

  • High level of coaching skills to lead and mentor the development of regulatory teams.

  • Good project management skills with the ability to oversee multiple projects simultaneously.


Are You?

  • A strategic thinker with an appreciation of the commercial objectives for the wider business.

  • Effective in communicating with senior level management, external Teva partners and with Regulatory Agencies.


If so – we would value hearing from you!

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.


The deadline for internal applications for this position will be Tuesday 23rd May 2023 #TJ

Teva’s Equal Employment Opportunity Commitment

At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.

Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That is why we are constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice.

Regulatory Affairs Manager
Teva Pharmaceuticals

www.tevapharm.com
Petah Tikva, Israel
Richard Francis
$10+ billion (USD)
10000+ Employees
Company - Public
Biotech & Pharmaceuticals
1901
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