Regulatory Affairs CMC Senior Manager

RM IT Services GmbH


Job ID :

12041


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

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 :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

upto 15%





Description

Regulatory Affairs CMC Senior Manager knowledge 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
* 4+ years' work experience in regulatory submission and approval processes for new chemical entities (NCE) and product life cycle management
* Proven practical knowledge of complex CMC regulatory issues and requirements as well as track record of successful work in interdisciplinary teams, leading activities simultaneously on multiple projects
* Ability to contribute line functions or project teams as well as to matrix teams with the necessary strategic thinking
* Demonstrated ability for risk assessment, mitigation and awareness of business impact

* 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, maximising the business benefit balanced with regulatory compliance
* Communicating CMC regulatory strategy and key issues throughout the life cycle in an adequate and timely manner to interdisciplinary project teams and respective departments
* Implementing all global CMC submission activities 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
* Leading Health Authority interactions and negotiations, setting objectives, preparing briefing books, coordinating and planning rehearsals and risk mitigation plans

Start: ASAP
Duration: 12MM+
Location: Basel, Switzerland
Ref.Nr.: BH13075

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.

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