Senior Manager Global Regulatory Affairs

Lawrence Harvey

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Job ID :

10285


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science


Address 1 :

Western Europe,--Frankfurt,Frankfurt am Main,


Key Skills :

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


Salary :

Negotiable


Date Posted :

02 Feb, 2018



Company Name :

Lawrence Harvey


Location1 :

Frankfurt am Main




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

Senior Manager Global Regulatory Affairs (m/f)

Medical Devices

Frankfurt



A top client, located in Frankfurt is currently searching for their next Senior Regulatory Affairs Manger to join their highly successful team. The company have a firm leading hold of the area of the market they are active in, and are highly successful on a global scale. They boast a highly attractive portfolio of products, with a high commitment to long-term growth and success and are working on a clear business strategy to ensure this is met.



The Role:



* Timely and accurate preparation and submission of applications for new approvals and registration as well as answering Regulatory related queries on a global scale
* Compiling and updating the registration dossiers, advising the involved development departments on quality, analytical methods, preclinical and clinical development to ensure data acceptance globally
* Develop, achieve and obtain medical device approvals/registrations worldwide and associated labelling, taking into account the relevant legislation and regulatory guidelines
* Evaluation of dossiers of third parties
* Creation and updates of product information texts according to the Company Core Data Sheets and relevant guidelines as well as translation management
* Receipt of approvals/ life cycle management worldwide (preparation and submissions of registration renewals, change notifications, submissions, annual reports etc.)
* Coordination of change processes and their global implementation
* Adequate preparation and conduct of consultations with Regulatory authorities worldwide
* Coordinating regulatory projects, communication with third parties in regards to regulatory issues
* Support in the development of regulatory strategies, participation in project teams, contact person in relation to regulatory requirements
* Maintenance of regulatory database



Your Profile:



* Successfully completed studies in a Life Science related field such as pharmacy, biology, chemistry, or an engineering background
* 5+ years of experience in the international approval of Medical Devices
* Excellent English proficiency both written and spoken, any other languages are a bonus
* Good Microsoft Office skills
* Analytical thinking
* Well structured and precise work
* Ability to network with internal and external partners



If you are interested in this position or have any referrals to suitable candidates, please send your application in response to this advert or directly to d.perkins@sciproglobal.de


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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