Regulatory Affairs Manager

Lawrence Harvey

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Job ID :

3440


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,South East,South East England,


Key Skills :

Richard Williamson , Pharmaceutical


Salary :

Negotiable


Date Posted :

11 Aug, 2016



Company Name :

Lawrence Harvey


Location1 :

South East England




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

I am exclusively recruiting for a Regulatory Affairs Manager, to manage a small team and also to deliver high quality regulatory consultancy to clients on a range of projects.

My client is a very well established consultancy, with a fantastic work ethos. They are going from strength to strength, and the business is growing at a continual rate.



The job purpose of Regulatory Affairs Manager will be:

- To provide an excellent, professional service to clients.
- To manage a small team of regulatory professionals and contractors.
- To perform consultancy on a variety of regulatory projects and assignments.
- To deliver profit to the business

Management of the team and delivering profit:

- To allocate projects to team members, bearing in mind the complexity of the project, experience of the team and current workloads.
- To monitor progress of team members' projects to ensure objectives, timelines and budgets are met.
- To provide coaching and support to team members on their projects and workload, including strategic input as well as practical aspects of their roles.
- Management of the team in line with business objectives.
- Maintain the company's philosophy and work ethos.
- Support the Managing Director with business development activities, including the identification of new business opportunities with existing and new clients.
- To contribute to monthly team meetings by actively contributing to business discussions and team aims.

Managing your projects:

- To advise clients on regulatory strategy on a wide variety of regulatory issues which meet the client's needs, bearing in mind financial, resource and time constraints.
- Development, submission and approval of regulatory applications.
- To interpret and respond to regulatory questions to resolve issues.
- To assess scientific data and prepare scientific documents to support regulatory applications.
- To assist the Managing Director with the development and maintenance of regulatory systems to ensure regulatory compliance.
- To influence key players in the regulatory process, including Regulatory Agencies.
- To execute projects and monitor progress to meet defined objectives and timescales.
- To draft and review key regulatory documents including RMPs, Overviews, Summaries and responses to questions.
- To develop and maintain a thorough knowledge of European and EU national regulatory requirements and a working knowledge of other non-EU country requirements.

The ideal person will be driven, have great motivational skills, be a team player and have a thirst for success, not only of their team, but for the overall business.


For more information on this role, please apply to this advert or call Richard Williamson on 02033273072.

Lawrence Harvey is acting as an employment agency in regards to this position.
Visit our website www.lawrenceharvey.com and follow us on Twitter for all live vacancies @lawharveyjobs


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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