Regulatory Affairs and Pharmacovigilance Associate

Lawrence Harvey


Job ID :

8095


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,London,London,


Key Skills :

Marketing Authorisation Application. MAA. CMC.


Salary :

Negotiable


Date Posted :

01 Aug, 2017



Company Name :

Lawrence Harvey


Location1 :

London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

* Responsible for coordinating the preparation of documentation required for marketing authorisation application submissions by various departments and third parties.
* Support the regulatory team in reviewing the quality and technical part of the dossier for marketing authorisation applications and responses to requests for further information associated with such applications.
* Prepare responses to queries from the Health Authorities
* Review variation packages for licensed products
* Compiling Standard Operating Procedures, Working Instructions and Forms required in the Regulatory department.
* Use Quality Management System (QMS) to propose any changes within the company related to a product or procedure.
* Support the manager in developing software for internal use of preparing the submission dossier for marketing authorisation applications.
* Support the manager in reviewing internal processes and provide guidance in implementing any changes.
* Support the team with gap analysis between the registered dossier and plant practices through scheduled compliance checks.
* Support the team with documentation throughout the product life cycle, from initial submission up to maintaining approval packages.
* Train new members of the department
* Keep up-to-date with Regulatory guidelines.
* Supporting the manager with daily/activities which are required for the business


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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