Regulatory Operations Assistant *LI-MB1
Locations: Only Eastern European countries can be considered
We are currently looking for an experienced Regulatory Operations Assistant (document and submission publisher) to join our Strategic Regulatory Services (SRS) - you will be working within SRS, within a team of professionals who provide strategic and operational expertise in the area of Regulatory Affairs and Operations for Pharmaceuticals, Biologics and Medical Devices. In return, we will offer you a supportive and engaging working environment.
We would like for you to support clients in compliance with applicable regulation, the company’s Standard Operating Procedures, and project-specific operational agreements
Responsibilities:
- The primarily responsibilities of this job include:
- Responsible for all aspects of publishing submissions and/or submission components for internal review and signoff, and for submission to regulatory authorities.
- Preparation of published output for either paper or electronic formats ensuring high-quality documents in adherence with regulatory guidelines and internal processes within established time lines
- Maintain submission components associated with a regulatory submission, paper and/or electronic, as required. This may include, but is not exclusive to, setting up templates, updating procedures, and project tracking
- Assemble electronic and paper Regulatory Submissions and packages for US Food and Drug Administration, the European Medicines Agency, Health Canada, and other international regulatory authorities
- Perform quality review of Regulatory Operations team members work to ensure accuracy.
- Participate in submission teams, maintaining necessary liaison between both project leader, and when applicable, with client.
- Participate in and conduct formal interactions (face-to-face meetings, teleconferences, etc.) with project teams and clients.
- Assist in the design and implementation of new processes or initiatives within the department.
You will have:
- Experience working with current electronic regulatory standards (e.g., eCTD, SPL, IDMP) is an asset
- Fluent English
- B.Sc. degree in Health Sciences or Information Technology
- Proven knowledge of a variety of computer programs including MS Office, Adobe Acrobat
- Ability to effectively handle multiple simultaneous projects.
- The ability to get along with clients, to adapt to their priorities, and while providing strategic direction is important.
- Ability to maintain a high level of accuracy and attention to detail.
- Ability to work collaboratively as part of a team.
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