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Role Filled

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

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Locations

Amersham
Aylesbury
Hemel Hempstead
High Wycombe
Previous Listing
Date Updated
12 Nov 2024
Job reference
73078
Categories
Full Time
Permanent
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