CMC Regulatory Affairs Manager - Global company
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.
* 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 email@example.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.