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Manager, Regulatory Operations

Any EU Location
Permanent
Reference: 018193
Description

Regulatory Operations Manager

 

Locations:  Homebased or office based contracts where possible can be offered in Hungary, Bulgaria, Romania, Slovenia, Slovakia, Latvia, Poland, Czech Republic, Ukraine or Turkey only.

 

ICON are currently looking for a Regulatory Operations Manager to join our Real World Evidence team and can be based in one of the countries mentioned above.   Working within our Real World Evidence team, you will work with a team of professionals who provide strategic and operational expertise in the design and conduct of Post-Approval and commercialization programs for Pharmaceuticals, Biologics and Medical Devices. 

 

Combining the industry’s oldest and most experienced Clinical Outcome Assessments (COA) consultancies (Mapi & Oxford Outcomes), within ICON Commercialisation and Outcomes, and with access to more combined COA experience than all other CROs and consultancies, we can offer fantastic career opportunities. We provide a dynamic, stimulating and rewarding working environment for ambitious and passionate individuals looking to join a global, world-class consultancy business.

 

Your Responsibilities and Accountabilities:

 

The  Regulatory Operations Manager  is responsible for Regulatory Operations duties to support clients in compliance with applicable regulation, the company’s Standard Operating Procedures, and project-specific operational agreements.

 

The role is responsible for submission project management, for securing new business, facilitating issue resolution, ensuring project / program timelines and budgets are met and maintaining client relationships in support of future business. 

 

 

Responsibilities:

 

In the role of Regulatory Operations Manager, you will be: 

  • Responsible for oversight of regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required.
  • Responsible for providing advice and support to the project team for regulatory  aspects  of the projects. 
  • Responsible for providing regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form. 
  • Responsible for investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly. 
  • Responsible for providing input and oversight for ongoing development and enhancement of systems used in the frame of Regulatory Affairs activities. 
  • Responsible for updating and maintaining regulatory information in the Study Management System and/or reporting mechanism, and for ensuring appropriate paper and electronic filing. 
  • Responsible for liaising with other departments on requirements for regulatory submissions. 
  • May act as a Contract Specialist if appropriately trained. 
  • Participating in the improvement of the Quality Assurance System.
  • Coaching and mentoring more junior members of the team

You will have: 

  • B.Sc. or advanced degree in in Health Sciences or Information Technology / Computer Sciences or equivalent relevant experience and training. RAC certification an asset.
  • Extensive experience working with current electronic standards (e.g., eCTD, SPL)- is  required
  • Experience in supporting business development activities an asset.
  • Solid background in Regulatory Operations
  • Excellent project management skills are required, as is the ability to effectively manage multiple simultaneous projects.
  • Ability to manage people, time and resources while developing a supportive team environment
  • The ability to interact with clients, to adapt to their priorities, and while providing strategic direction is essential.
  •  Ability to participate and contribute in standards development organizations
  • Presentation at industry conferences, publications in regulation affairs.

 

Next Steps:

 

Following your application you will be contacted by one of our dedicated recruiters and if successful we will be able to provide you with more details about this opportunity.

 



ICON Plc is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.




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