Regulatory Affairs Team Leader - Willey | 29354 | Zoek UK
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Regulatory Affairs Team Leader
Willey, Warwickshire, England
Permanent (Full time)
Regulatory Affairs Team Leader
Avantor is a Fortune 500 global leader in the provision of essential products and services to the life science industry. In addition to our extensive portfolio of products, we provide a broad variety of on-site Laboratory and Operational Services for major pharmaceutical customers and work collaboratively with the client to provide resource to deliver agreed activities.
We’re looking for a Regulatory Affairs Team Leader who will provide regulatory guidance to the Commercial and Operations in accordance with applicable local regulatory requirements and will support the implementation of these local legal requirements to ensure that the company implements the necessary changes.
Working hours: Monday-Friday core hours
Location: Can be based in either the UK or Ireland
What you’ll do on a typical day:
* Will be responsible for all day-to-day regulatory affairs within the assigned regional RA hub
* Support the business to resolve daily regulatory queries and ability to advise and provide recommendations on regulatory matters
* Develop team spirit and teamwork within the assigned hub
* Sets operational goals for team members in conjunction with the defined strategic priorities
* Identify problems and update working methods in own role with the benefit of defined procedures.
* Communicate and cascade decisions/requests from Central RA team down to local RA
* Escalation of issues to the RA senior leadership
* Supervision of the local legislation vigilance: Constant monitoring of the upcoming regulatory changes within the local area and provide regulatory guidance to Commercial and Operations of the assigned regional hub.
* Provide guidance (regulatory & operational support) to local RA
* Participate/guidance for local RA inspections and for attorney – client privileged topics, including remediation plan follow-up
* Follow up contacts with the necessary competent Authorities.
* Find synergies within the hub (process harmonization)
* Facilitate back-up for Local RA through cooperation within the hub
What you’ll need to be successful at Avantor:
* Background and demonstrable experience in Regulatory Affairs, ideally in a Chemicals or Biopharmaceuticals industry
* People management experience is desirable but not essential
* Academic experience in either a Life Science subject or related (such as Engineering)
* Clear and concise written and spoken communication skills
* Proficient in various IT systems, particularly Microsoft Word and Excel
* Comfortable with working autonomously, motivated towards achieving goals
What we offer:
Here at Avantor, we focus on you. Along with a competitive salary, we will offer you a modern environment where you can feel at ease while gaining practical experience, expanding your knowledge, and focusing on your personal growth