Associate Director Regulatory Affairs

Lawrence Harvey

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Job ID :

8123


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,London,London,


Key Skills :

Biologics. Post Marketing. EU Post marketing.


Salary :

Negotiable


Date Posted :

03 Aug, 2017



Company Name :

Lawrence Harvey


Location1 :

London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

PRIMARY DUTIES

* As Associate Director Regulatory Affairs, you'll collaborate to define, develop and lead global and/or regional strategies to maximize regulatory success.
* You'll effectively communicate objective assessments of the likelihood of success of these regulatory strategies. Provides strategic and tactical advice and guidance to teams to achieve timely and efficient conduct of development programs and/or oversight of marketed product support, while maintaining full compliance with applicable regulatory requirements.
* Provide regulatory expertise for multiple projects or one complex development project and / or marketed product(s) of responsibility.
* Manage and trains direct reports and / or mentors team members, if required, to support scope of project work.
* May be called upon to act as deputy to the Global Regulatory Lead, therapeutic area head and/ or Region regulatory head, and/or Marketed Products Head, attending internal leadership team meetings, as appropriate.

QUALIFICATIONS / EXPERIENCE REQUIRED:

* To achieve the objectives of Associate Director Regulatory Affairs you'll need the following background:
* BSc degree or equivalent in science; advanced degree preferred.
* Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or post-marketing phases.
* Solid working knowledge of regulations and guidance's governing drugs and biologics in all phases of development, including post-marketing, in the EU.
* Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
* Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.

Before you apply for this position it is vital that you are in possession of an EU or UK passport or relevant visa to work without restrictions in the 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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