Regulatory Affairs CMC Manager

RM IT Services GmbH


Job ID :

12042


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bachelor of Business Administration,Master of Businees(MBA),Master of Science


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

cGMP, GMP, GxP, RegCMC, Regulatory Affairs,


Salary :

Negotiable


Date Posted :

29 Jun, 2018



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

upto 15%





Description

Regulatory Affairs CMC Manager wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

* Degree in Science, e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology, or equivalent
* 2+ years' work experience in regulatory affairs preferred as well as working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology
* Demonstrated track record of successful work in interdisciplinary teams, planning, coordinating and executing activities simultaneously on multiple projects
* Ability to critically evaluate data from a broad range of scientific disciplines and a reasonable approach to risk assessment
* Expertise in regulations, guidelines for NCEs and product life cycle maintenance

* Languages: fluent English both written and spoken, well-spoken German desired

Your tasks:

* Determining and leading global CMC regulatory strategy for development projects or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance
* Communicating CMC regulatory strategy, key issues and any other critical topics throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and respective departments
* Implementing all global CMC submission for assigned projects, while applying the global strategy into submissions
* Authoring high-quality CMC documentation for HA submission, applying CMC global regulatory strategies, assuring technical congruency and regulatory compliance
* Maintaining a single point of contact with FDA or country affiliates, RA regional and TA groups for all communication on development and marketed products
* Initiate and leading Health Authority interactions and negotiations as appropriate as well as driving cross-functional CMC Health Authority Response Teams (HARTs) for as-signed development

Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13074

Does this sound like an interesting and challenging opportunity to you? Then take the next step by sending us your CV as a Word document and a contact telephone number.

Due to work permit restrictions we can unfortunately only consider applications from EU or Swiss citizens as well as current work-permit holders for Switzerland.

Going the extra mile…

New to Switzerland? In case of successful placement, we support you with:

* All administrative questions
* Finding an apartment
* Health - and social insurance
* Work permit and much more


Company Name:

RM IT Services GmbH


Headquarters:

Hackescher Markt 2-3,


Sector:

Staffing Firms


Country:

Germany


Zipcode:

10178


Website:

www.rmgroup.ch


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


Phone No. :

+41583560693


Professional Resources, Professional Services Since its establishment in 1998, the RM Group has developed to become one of the leading companies in the field of IT Resources Management in Switzerland. As a specialised recruitment agency, we find highly qualified experts for your projects. This is the basic requisite for the targeted development of IT strategies and for the practical implementation of IT projects. The RM Group is among the few significant Swiss recruitment agencies which fulfills all requirements related to compliance and quality assurance per ISO 9001, ISO 14001, GoodPriv@cy® and EcoVadis certification.

For more information,visit www.rmgroup.ch.

View all RM IT Services GmbH Jobs



© 2018 Jobsinpharma - 4ward Technologies Ltd All rights reserved.