Regulatory Affairs Manager

Lawrence Harvey


Job ID :

13157


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,East Sussex,East Sussex,


Key Skills :

regulatory affairs, cta, clinical, development, post approval, registrations, manager, team leader,


Salary :

£50000 - £54000 per annum + bonus and benefits


Date Posted :

08 Oct, 2018



Company Name :

Lawrence Harvey


Location1 :

East Sussex




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for a Regulatory Manager / Team Leader to join a global team within a specialist Pharmaceutical company based on the south coast. Within this role you will gain a large amount of exposure working closely with R&D, QA and PV teams and lead a team of Regulatory professionals.

Job Specific Responsibilities:
- Line manage a team of regulatory officers and senior officer
- Ensure regulatory systems, such as Regulatory Database /trackers are implemented and kept up to date.
- Work with internal & external customers to provide data and accurate regulatory input
- Prepare & review labelling/Packaging text. Promotional reviews *Communicate with regulatory agencies and document communication
- Prepare, Review and sign off change control risk assessments
- All paper and electronic files kept up to date and easily locatable
- Input into team activities e.g. brainstorming, best practices etc.
- Prepare & review assigned SOPs
- Prepare & review new product dossiers and annual updates
- Preparation & review of high quality timely submissions/responses and follow up of actions arising from Regulatory Authority commitments
- Review and approval of CTA/IND submission and maintenance documentation
- Prepare & review new product dossiers and annual updates

Qualifications/Experience required:
- Relevant life sciences degree
- Minimum of 5+ years in the pharmaceutical field
- Ideally previous line management experience
- Demonstrated ability to write good quality documents
- Communication skills
- Attention to detail/accuracy
- Project management
- Breadth of technical regulatory knowledge & regulatory procedures in a variety of markets
- Proficient user of Microsoft Office

For further details about this role or other opportunities within Regulatory Affairs please contact Tim Barratt on +44 (0) 1727 817 626 or email a copy of your CV to 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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