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CMC Regulatory Affairs Manager - Global company

Employer
NonStop Consulting
Location
Austria
Salary
€45000 - €75000 per annum + 25 days holiday + heathcare
Closing date
Feb 25, 2018

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Sector
Pharmaceutical, Quality Assurance
Contract Type
Employee
Hours
Full Time
Organization Type
Corporate
Jobseeker Type
Professional

Job Details

NonStops Client is searching for a Senior CMC Regulatory Manager to join their team in Austria. This position will be responsible to review and content creation of global regulatory CMC submissions for various products in development, global registrations and approvals, and post-marketing life cycle support.

Primary responsibilities are to garner successful approvals of regulatory submissions, to meet health authority (HA) commitments, to maintain global registrations and other regulatory activities as assigned to ensure compliance with biologics product registrations. A key success indicator is the ability to learn the clients' regulatory compliance systems quickly. Project work will range from administrative (formatting per client guidelines, obtaining information in client systems) to complex (developing regulatory strategies for global rollout of post-approval CMC changes and authoring associated submissions) and is dependent upon the needs of the client.

Job Responsibilities:
* Preparation of requests for Scientific Advice from FDA, EMA and EU National Authorities
* Support for customers in Regulatory Authority meetings; advice on regulatory strategy; due diligence on existing data packages
* Advice on individual study designs, considering product type and therapeutic class, and review and interpretation of study data
* Participates in product development team meetings to ensure inclusion of CMC requirements across various stages of the drug development/approval process. Provides guidance to client on issues impacting CMC information.
* Develops regulatory strategies for post-approval CMC changes by utilizing existing regulatory affairs knowledge and client systems/ processes.
* Continues to develop familiarity with regulations and regulatory guidelines and strategy
* Develops working knowledge of regulatory standards, practices, corporate policies, practices and departmental SOPs/work practices.

In order to be considered you should have
* 3+ years experience within regulatory affairs, CMC focused role
* Ability to work in a team and on your wn (management experience)

* cGMP experience.

If this role is of interest to you then do not hesitate to get in contact today as my client is looking to select suitable CV's in the next week. Please send your CV in MS Word format (I am unable to accept PDF copies!) to me directly, Ruby Wallace, at r.wallace@nonstop-recruitment.com, or by calling me on 02079402105 for a discussion in confidence.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.

Company

Our Consultants are trained to deliver an exceptional standard of recruitment services to clients across the life sciences, chemical, care, educations, technical, digital and finance industries. 

Our clients – and bottom line profits - tell us that we do a great many things very well. Complacency, however, is the last word you would associate with us. We work incredibly hard to deliver better and better results, based on stronger and stronger service delivery.  Which is why we believe the best is yet to come – for us, our clients and for the people who have what it takes to join us on the journey.

The result? We’re expanding (in the UK and across Europe and even to Boston, US) and continue to post impressive performances in all our niche sectors. 

Company info
Website

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