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Regulatory Affairs Associate

Date: Mar 13, 2019

Location: Harlow, GB, CM20

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

We are currently searching for a Regulatory Affairs Associate to join our European Generic Regulatory Affairs Team, based at our office in Harlow, Essex.  You will work in a large team of regulatory affairs professionals, working in a key hub of Teva’s Regulatory Affairs organisation. Within this role you will be responsible for supporting and submitting new marketing authorisation applications and expediting submissions/approvals for a range of generic products.

Key responsibilities:


• To focus on European projects.  Work with your line manager to perform activities for both new generic submissions and post approval activities via decentralised and mutual recognition procedures.  Typical products include solid oral dosage forms, solutions and/or suspensions.

• Work closely with your manager and R&D sites or third party partners, supporting the preparation, compilation, review and submission of high quality regulatory dossiers and post marketing documentation in accordance with EU requirements and company SOPs. 

• Support regulatory submissions from development through to first launch; take an active role in the project team; working with your manager to co-ordinate the preparation of submission documents with a view to critically evaluating data, reports, MAA modules and response documents before submission of the final documentation to the National Competent Authorities.

• To proactively support the team members; to actively work with colleagues and/or on projects as required. 

• To co-ordinate resource effectively with a view to ensuring that high quality documentation is available in a timely manner and meets specified project timelines/milestones.

Qualifications

 

Minimum Qualifications
• Scientific degree in Pharmacy/Chemistry or a Life Sciences subject.

Knowledge
• Knowledge of Regulatory Affairs and the pharmaceutical industry, ideally with knowledge of EU regulatory procedures and requirements.
• An understanding of the technical aspects of drug development and familiarity with the quality sections of the Registration dossier would be an advantage.

Skills
• Excellent verbal and written communication.
• Time and organisation management.
• Attention to detail.
• Analysis/problem solving.
• Self-motivated and driven.

 

If you have EU Regulatory Affairs experience and would like to work in a fast paced and dynamic environment, then we’d love to hear from you!

Function

Regulatory Affairs

Sub Function

Medical Regulatory Affairs

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.