Regulatory Affairs Associate - Chippenham, United Kingdom - Alliance Pharma

Tom O´Connor

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Description

We are a leading international healthcare business of inter-connected people and brands with a global range of products delivering outstanding value.

From its origins in the UK 20 years ago, Alliance has grown to become a significant international healthcare group.

We employ over 200 people, located in ten offices around the globe.

Our international presence is further enhanced by an extensive network of distributors enabling us to serve customers in more than 100 countries worldwide.

We have a successful business with a strong collaborative culture, and we recognise that our relevance and value is in how we work together.

Our UK business has been recognised as a Great Place To Work two years consecutively.


We are now recruiting for a Regulatory Affairs Associate, to join our central Pharma group, to provide support for regulatory activities related to our medicinal products in the EMEA territories.

Your role will help us maintain compliance to achieve more for patients, healthcare providers, business partners and investors.

As our new Regulatory Affairs Associate, some of your key contributions to the team will include:

  • Support the preparation and submission of documents for regulatory submissions (includes consolidation of information and data into the relevant dossier format)
  • Responsibility for complete and accurate data entry and/or QC of databases (may include reports and metrics)
  • Support, maintenance and QC of product information and product artworks by following Alliance systems/processes
  • Support and may be responsible for, projects (such as integration of acquisition projects)
  • Building relationships with internal and external stakeholders (including competent authority personnel), using best practice
  • Time management, prioritization, and the ability to make recommendations based on technical knowledge and understanding of the regulatory environments
  • Ongoing training and professional development activities to fulfil departmental goals. Be responsible for, the training of others which may include mentoring
You will have the following skills to thrive at Alliance:

  • Demonstrated ability to work as part of a team
  • Adaptability to be able to thrive in continually evolving environment
  • Ability to adhere to internal and external deadlines
  • Demonstrated ability to maintain attention to detail
  • Good interpersonal skills with initiative to understand problems and propose solutions

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