Regulatory Affairs Manager - Pharma or Combination Products

Lawrence Harvey

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Berlin,Berlin,

Key Skills :

Regulatory Affairs,ISO 13485, Pharmaceuticals, Medical Devices, CMC, Pharma, Senior Regulatory Affa

Salary :


Date Posted :

08 Aug, 2017

Company Name :

Lawrence Harvey

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



I am currently in the search for a Regulatory Affairs Manager with experience in the Pharmaceutical (Combination Product) sector

Your tasks

* Approval strategies for combi products

* Maintenance of existing approvals for combi products

* Variation notifications

* Choice of new drug suppliers

* Interface management to health authorities both inside and outside Europe, but also globally

* Creation and maintenance of Common Technical Documents for Combination Products (eCTD)

* Consult the responsible R & D managers in the development and validation of new combination products

* Independent updating / development and implementation of measures for new requirements for combination

products at home and abroad

your qualification

* Successfully completed pharmaceutical or natural sciences studies or equivalent qualification

* Several years of professional experience in the authorization of pharmaceutical products or combination products

* Sound knowledge in the creation of eCTDs

* Negotiation skills and communication skills

* Strategic, analytical, entrepreneurial thinking

* Very good knowledge of English in spoken and written English

* Ability to work with MS Office

Company Name:

Lawrence Harvey


150 Leadenhall Street,London


Staffing Firms


United Kingdom





100 - 499


Pharmaceutical Recruitment



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

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