Reference Number: JO-2401-528333
Senior Regulatory Affairs Manager/ Consultant
Job Type: Contract
Senior Regulatory Affairs Manager/ Consultant – 12 Months Contract
Berkshire, UK – Hybrid
We are partnered with a leading Pharmaceutical organisation who are looking for an experienced Regulatory Consultant to join on a 12-month contract basis. This product will support a combination product portfolio and will be driving European Regulatory Strategies and must be experienced in interacting with EU health authorities.
This role will require the right candidates to have experience with EU submission for medicines and combination products.
Job Responsibilities include;
· Define and implement Area & Affiliate regulatory strategies & deliverables for a portfolio of compounds typically marketed for the European area.
· Identify and advocate region’s requirements in the overarching global regulatory strategy; and make sure it is taken into account at the Global Regulatory Project Team (GRPT).
· Primary Regulatory Affairs (RA) interface with Commercial and in collaboration with the Regulatory Affairs personnel in the affiliates.
· Ensure combination product development activities are compliant with quality and regulatory standards, both internal and external.
Candidate Requirements include;
· Eligibility to live and work in the United Kingdom
· Previous experience working on combination products
· A Life Sciences degree or equivalent
· 5 years of Regulatory experience with a strong background in EU submissions.
Please note this position falls inside IR35 and has no opportunities to go through LTD, if this position is of interest to you please forward your up-to-date CV to email@example.com