Regulatory Affairs Manager

Lawrence Harvey


Job ID :

8859


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,


Key Skills :

regulatory affairs, manager, marketed products, post approval, CMC, hertfordshire,


Salary :

£55000 - £65000 per annum + bonus and benefits


Date Posted :

26 Sep, 2017



Company Name :

Lawrence Harvey


Location1 :

Hertfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Reporting into the Head of Regulatory Affairs, within this role you will be responsible for the registration of new products and the maintenance of existing products.

Essential main job functions:
*Manage the regulatory submissions including Marketing Authorisation Applications for innovative regulatory pathways (Centralised Procedure, Mutual Recognized Procedure or National requirements), Variations and Renewals.
*Prepare and submit Marketing Authorisation dossiers in Europe and Rest of the World
*Responsible for the regulatory management of medical devices (Europe and Rest of the World) either for manufacturer or distributor
*Establish key contacts within the various Health Authorities
*Responsible for creating, updating, reviewing and approving product information (leaflets, labels, boxes, SPCs etc.) and promotional materials

Additional Requirements:
*Management of the CMC activities with in line with pharmaceutical development, maintenance and strategy
*Maintain a strong working relationship with the medical/pharmacovigilance and marketing/ commercial teams
*Contribute to the implementation of the regulatory strategies for new product
*Manage regulatory intelligence
*Involvement with reimbursement/pricing dossiers

Experience/qualifications required:

*Excellent communication skills
*Ability to build relationships with key stakeholders both internally and externally in order to obtain quick approvals
*Able to work independently, with moderate supervision on multiple projects and within multi-disciplinary teams
*Previous experience of regulatory requirements for launching a new product
*Second European language ideal but not essential
*Educated to degree level or equivalent

For further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk



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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