Looks like you’re on the UK site. Choose another location to see content specific to your location
Pharmaceutial & Biotechnolgy
Back to search
Business Development Manager
Pharmaceutial & Biotechnolgy
Export Sales
Pharmaceutical / Women's Health
Hemel Hempstead (site based)
£40 - 55K
Womens Health/neonatal
Role Overview
You will manage regulatory submissions for Pharmaceutical products in the UK and EU, reporting to regulatory authorities.
Company Information
Zenopa is partnered with a privately owned British company offering a range of medicines, medical devices, unlicensed medicines, and OTC products.
Since it was established, our client has developed a differentiated portfolio of over 150 Market Authorisations, holds the ISO13485 accreditation and is the legal manufacturer and distributor of a range of medical devices.
Their commercial coverage extends across the entire UK mainline and shortline wholesale channels, private and NHS hospitals, community and retail pharmacies and Clinical Commissioning Groups.
Role Requirements
Manage life cycle/ post-authorisation changes for the UK relating to CMC, clinical, safety and product information changes.
Write, compile and publish dossiers for UK National & EU Submissions.
Compile information and data for amendments to marketing authorisations.
Develop and approve artwork components and patient information and associated mock-ups.
Prepare Artwork Submissions that include P1 Applications, Article 61 (3) Notifications.
Liaise with the External Pharmacovigilance consultants for submission of Safety variations and PSUSA Variations.
Person Specifications
Previous Regulatory experience within the Pharmaceutical industry.
Experience dealing with submissions using MHRA and CESP Portals.
Ability to take initiative.
Strong problem solving skills.
Package
Bonus scheme
31 days holiday
Health insurance
Company mobile/laptop.
Pension scheme
Even if you do not fit the criteria, we still want to hear from you! We have over 300 jobs not advertised on the website that you could be a perfect fit for.
Apply for this role
Locations
Amersham
Aylesbury
Hemel Hempstead
High Wycombe
Date Updated
12 Nov 2024
Job reference
73078
Categories
Full Time
Permanent
Take Experience
Share Job
Copy link
Copied to clipboard
Related Jobs
The Zenopa Salary Guide is based on Zenopa industry experience, it is not specific to this particular job, but it is useful to provide you indicative information and enable you to find jobs when searching salary bands. Individual jobs salary ranges are frequently not released into the public domain, this will be released to you upon application.
Why Zenopa?
We aim to operate and maintain the following set of core values
