Regulatory Consultant
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Regulatory Consultant job at a leading multinational biopharmaceutical company with leading therapies in autoimmune diseases and oncology. They are seeking an individual to bring solid regulatory affairs experience their team at their offices in [location. This is an exciting opportunity to work for one of the world's biggest biotechnology firms that employs over 17,000 staff globally.
The Regulatory Affairs Senior Associate will assist in the creation and submission of regulatory documents for one or more assigned projects.
Job Responsibilties:
- Assist Regional Regulatory Lead to support regional regulatory filing activities (e.g. core CTA/IMPD development and submission)
- Provide and maintain CTA/MA documentation (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead
- Coordinate collection of functional documents in support of regulatory applications
- Prepare regulatory packages and cross-reference letters to support investigator sponsored studies
- Actively support regulatory compliance, and ensure compliance via timely submissions to regulatory agencies
- Create and maintain product regulatory history documents through company systems and appropriately archive all regulatory documents and agency communications
- As appropriate may participate in GRT to support execution of regulatory strategy
- Respond to specific requests from and communicate relevant issues to GRT
- Support the development and execution of GRT goals
- Review regional component of the Global Regulatory Plan and provide input to operational deliverables
- May support RRL in review of promotional materials for commercial activities
- Provide regulatory support to Commercial, Medical and Clinical departments through cross-functional interactions in brand and therapeutic area teams
- Support process improvement initiatives, standards development, and metrics
Skills and Requirements:
- Strong communication skills - oral and written
- Organizational skills
- Understanding of drug development process
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 call Peter Duvall on +44 203 0789 542 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.
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.