Regulatory Affairs Manager
Job Title: Regulatory Affairs Manager (m/w)
Location: Ludwigshaven, Germany
TalentSource Life Sciences, the division of CROMSOURCE dedicated to flexible staffing solutions, is currently recruiting for a Regulatory Affairs Manager (m/w) to strengthen the team of one of our TOP Pharmaceutical client Companies in Ludwigshaven, Germany.
Main Job Tasks and Responsibilities
· Obtain marketing authorizations for new pharmaceutical products
· Maintain marketing authorizations as required
· Liaise with European Regulatory Affairs and Corporate groups on regulatory matters
· Liaise with national regulatory authorities as required
· Comply with the Company's policies and procedures to assure consistency of the current local prescribing information with the CCDS in order to:
o Ensure alignment within the organization
o Meet the expectations of regulatory agencies
o Implement approved label through defined artwork process
· Liaise and attend meetings with other company functions to provide regulatory advice for new and existing products, including participation within affiliate Brand Team
· Main responsibility for arrangement of national Scientific Advice with national Competent Authorities
· Maintain awareness of current and new legislation/guidance and ensure that work is in compliance with the statutory requirements
· Write and update local procedures in compliance with the local regulation and internal policies and procedures, if applicable
· If required, coordinating the review of parallel import samples
· Review of promotional and non-promotional materials in accordance with legislation, local procedures and codes of practice
Education and Experience
· Experience of working in a regulatory environment
· Good communication skills, both verbal and written
· The ability to thrive in a changing environment and to re-prioritise workload to meet business needs
· Good project management skills essential
· Very good English language skills
If you have the experience needed for this position, please contact Alexander Sourounis, Senior Consultant TalentSource Life Sciences Unit, and send your CV in WORD format to email@example.com
Why TalentSource Life Sciences/Cromsource
CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.
Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.
Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.
As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.
To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.
Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.
Regulatory Affairs Manager