Regulatory Affairs Director

Lawrence Harvey


Job ID :

6961


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Surrey,Surrey,


Key Skills :

Richard Williamson , Life Sciences , Regulatory Affairs


Salary :

Negotiable


Date Posted :

26 Apr, 2017



Company Name :

Lawrence Harvey


Location1 :

Surrey




Job Category :

Clinical Monitoring Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

We are currently seeking an experienced and highly motivated Regulatory Science Professional for the position of Director, Regulatory Science, Drugs & Biologics.



The ability to lead by example in a positive environment is paramount in order to support our dynamic team. Our projects include the design and implementation of innovative drug/biologics development strategies and the preparation of regulatory submissions.



Responsibilities:

* Participate as team member, leader, or advisor in a number of the company's international projects, in an international environment;
* Define and implement regulatory strategies for development and registration of innovative drugs and biologics;
* Write, review and assemble high quality regulatory submissions, such as Marketing Authorisation Applications (MAAs), Variations and Extensions, Orphan Drug Designations (ODDs), Scientific Advice briefing documents, and Paediatric Investigation Plans (PIPs);
* Contribute to the development of the activity of our European offices, both by growing the existing projects and by generating and taking charge of new projects. This includes meeting with prospect clients, coordinating the writing of new proposals for collaboration, and developing an efficient working relationship with the clients;
* Monitor, prioritize and supervise projects' strategy, timelines, and milestones and communicate them to the project team members. Experience in large projects management is required (such as MAAs);
* Ensure compliance with regulations and applicable guidelines;
* Attend and present at conferences and/or write articles in your area of experience/expertise as needed;
* Contribute to training/coaching of junior consultants.

Experience:

* An advanced degree in Pharmacy, Medicine, Biology, Engineering, Chemistry or related discipline;
* A minimum of 10+ years' experience in Regulatory Sciences, including experience of Drug Development and writing of technical documents of ODDs, parts of MAAs (e.g. nonclinical, clinical), briefing documents;
* Experience as a consultant (e.g. in a CRO) would be an asset;
* Excellent written and verbal communication, presentation, and facilitation skills;
* Ability to conceive and deliver the optimum creative development and regulatory strategies;
* Proven negotiation skills and significant experience in interacting with regulatory authorities;
* Experience with Project Management of complex/large projects is required;
* Line management experience would be a plus.

Personal attributes and skills:

* Proven ability to meet deadlines;
* High motivation and flexibility;
* Client- and business-oriented;
* Excellent communication and negotiation skills;
* Risk management and problem solving skills;
* Ability to lead, mentor and develop others for future growth and development;
* Ability to work in a multicultural environment;
* Ability to manage and build relationships with colleagues;
* Proactive and enthusiastic approach to collaboration with internal and client teams;
* Ability to work in compliance within a Quality Assurance system;
* Strong written and verbal communication, presentation, and facilitation skills;
* Fluent in English, knowledge of a second European language would be an asset;
* Excellent working knowledge of MS Office (Word, Excel, PowerPoint) is essential.

Please contact Richard on 02033273072 or apply to this advert to hear more


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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