CMC Regulatory Manager

RM IT Services GmbH

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Job ID :

13794


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Master of Science,Medical Doctor,phD


Address 1 :

Western Europe,--Basel,Basel,


Key Skills :

cmc, regulatory


Salary :

Negotiable


Date Posted :

18 Dec, 2018



Company Name :

RM IT Services GmbH


Location1 :

Basel




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Regulatory Manager with profound CMC knowledge wanted for our Basel based client in the pharmaceutical sector.

Your experience/skills:

* Science based Bachelor's or Master's degree, higher degree, like MD, PhD or PharmD, preferred
* 2+ years' experience in regulatory and drug or biologic development spanning activities in Phases I-IV including a sense of post-marketing and brand optimisation strategies, commercial awareness is beneficial
* Familiarity with regulatory submission and approval processes in at least one major region
* Skill set consisting of social intelligence and abilities, negotiation expertise and solution finding proficiency
* Languages: fluent English both written and spoken, other languages advantageous

Your tasks:

* Implementing regulatory strategy and controlling operational activities for assigned regions
* Giving input on global regulatory strategy and contributing to Regulatory Functional Plan and Seed Document, or their equivalents, including classification of gaps or risks in global strategic plans for set regions
* In charge of submission of Clinical Trial Applications, CTAs, and Investigational New Drugs and INDs
* Managing, planning, and arranging submissions of dossiers in assigned regions at a global scale
* Securing regulatory compliance for assigned projects and maintaining records of all major Health Authority interactions in the validated document management system

Start: 01/2019
Duration: 07MM+
Location: Basel, Switzerland
Ref.Nr.: BH13887

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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