Regulatory Affairs Associate
This vacancy has now expired. Please see similar roles below...
An international pharmaceutical company is seeking to hire a Regulatory Affairs Associate to their office in Brussels. The organisation produces health, hygiene, and home products, along with other multinational consumer goods. This is an exciting opportunity to provide regulatory expertise, ensuring that all regulatory activities are carried out according to best process.
Job Responsibilities:
- Manage a complex and diverse set of registration/regulatory requirements across multiple markets and brands to enable the strategic delivery of a global pipeline.
- Contribute to the development of regulatory strategies to enable successful registration in global markets with a focus on New Product Development.
- Maintain and develop knowledge and intelligence across the Regulatory Function to build 'right first time' approach with respect to registrations globally.
- Collaborate with partner functions to agree market specific data requirements and delivery timelines.
- Develop excellent working relationships with local (regional) regulatory colleagues to facilitate aligned regulatory plans and shared learnings to ensure efficient speed to market.
- Create strong and proactive relationships with all partner functions.
- Work collaboratively with Snr Manager/Manager in order to define and implement the regulatory strategy.
- Assist in monitoring, collecting, interpreting and sharing with business partners, regulatory issues and trends that will impact RB products, policies and procedures. Assist in the development of strategies and plans of action to address them.
- Assist in the preparation of responses to address significant safety, regulatory and PR issues in the assigned Category.
Skills and Requirements:
- Educated in a scientific field or equivalent experience. Honours degree is a plus.
- Minimum 6 months regulatory experience and knowledge in dossier / technical file creation, variations and renewals.
- Ideally experience in medical products (preferably OTC) regulations. Other regulations would be a plus e.g. medical devices, cosmetics.
- Understanding of global product development practice, rules, regulations and guidelines.
- Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines relevant to dossier deliveries.
- Fluent in English, Dutch, and a strong preference for French, or French language skills that can be developed.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Roberto Esposito at +44 203 761 5702 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
#LI-RE1
#RegulatoryAffairs
Related jobs
Highly Competitive
Frankfurt am Main (60488), Germany
Proclinical are seeing a Clinical Application Specialist for a position based in Frankfurt.
£45000 - £55000 per annum
City of London, England
Proclinical are searching for a dedicated professional for a Senior Clinical QA Specialist (GCP).
Up to £0.00 per annum
Zürich, Schweiz
Proclinical are currently supporting is a global management and technology consulting group as they are looking to recruit a Senior SAP FI/CO Consultant in Zurich, Switzerland.
Highly Competitive
Crailsheim (74564), Germany
Proclinical are seeking a dedicated Technical Project Manager to lead software development projects in the medical technology field.
Highly Competitive
Zürich, Schweiz
Proclinical are recruiting for a Senior Software Developer Java to join a consultant. This role is on a permanent basis and located in Zurich.
Highly Competitive
City of London, England
Proclinical are searching for a Clinical Project Manager for a fully remote role within the UK.
Up to US$27 per hour + Highly Competitive Salary
Philadelphia, USA
Proclinical Staffing is seeking a Cell Manufacturing Associate to join a cutting-edge cell and gene therapy company.
Highly Competitive Salary
Rockville, USA
Proclinical is seeking a dedicated and innovative QC Microbiologist with a focus on endotoxin detection methods. This is a contract position located in Rockville, MD.
Highly Competitive Salary
Cambridge, USA
Proclinical is seeking a dedicated Talent Acquisitions Coordinator. This is a contract position located in Cambridge, MA.
Highly Competitive Salary
Wilmington, USA
Proclinical is seeking a dedicated Senior Quality Specialist to provide leadership and oversight on GMP operations related to clinical manufacturing.