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Regulatory Affairs Associate

Boehringer Ingelheim
Job LocationBracknell
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeTemporary, full-time

Job Description

REGULATORY AFFAIRS ASSOCIATE (12 MONTH CONTRACT)OUR COMPANYAt BoehringerIngelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve; after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.THE POSITIONWe are currently looking for a Regulatory Affairs Associate to support the Animal Health business by assisting with product registration activities for marketed veterinary products in Great Britain, Northern Ireland and the Republic of Ireland.You will support the Head of Regulatory Affairs and Pharmacovigilance in the implementation of day to day local processes relating to the end of the Brexit transition period.You will be responsible for creating, maintaining and updating records in all relevant databases and documents/templates to ensure compliance of products.Tasks & responsibilities will include:

  • Assist in the activities of Local RA:- Assembly of regulatory submissions to obtain and maintain Marketing Authorisations in Great Britain, Northern Ireland and the Republic of Ireland in collaboration with RA Managers- Checking regulatory documents and artwork for accuracy- Communication with stakeholders- Monitoring inboxes
  • Maintain and update regulatory archives and other departmental filing systems, databases and trackers to ensure compliance with registered details and accurate record keeping according to company and departmental procedures. Includes regulatory submissions and correspondence and relevant internal emails.
  • Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information.
  • Organise and update status of the registration process to relevant stakeholders.
  • Raise/process purchase orders, special payment requests and support the invoicing process for the department
  • Support the Head of Regulatory Affairs and Pharmacovigilance in the creation/adaptation/implementation of day to day local processes relating to the end of the Brexit transition period.
  • Support the pharmacovigilance team during periods of high reporting to ensure all cases are entered into the database accurately, within timelines and according to internal procedures.
    • Requirements
  • Experience of working in a Regulatory or Technical role within the pharmaceutical industry
  • Knowledge of the animal health industry is desirable but not essential.
  • Relevant scientific degree
  • Strong planning and prioritisation skills
  • Process-oriented with ability to adapt quickly
  • Excellent communication and interpersonal skills
  • Proactive attitude, able to work on own initiative and willing to take on other tasks and help others as required.
  • Analytical and detail oriented
    • WHY BOEHRINGERINGELHEIM With us, you can grow, collaborate, innovate and improve lives.We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mind sets and practices. In addition, learning and development for all employees is key, because your growth is our growth.We also offer a competitive salary, generous amount of annual leave, numerous benefits towards your wellness & financial health and work-life balance. Plus a best-in-class subsidised cafeteria and coffee shop to keep you energized and healthy and other various benefits and rewards.To learn more about what benefits could be waiting for you, please visit our Career area.BoehringerIngelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

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