>Icon Clinical Research Released Job Openings On 23/01/2023.Icon Clinical Research Limited is an Indian multinational corporation that provides information technology, consulting and business process services. The Fortune India 500 ranks it the 29th largest Indian company by total revenue. It is also ranked the 9th largest employer in India with over 221,000 employees.Eligibility Criteria / Educational Qualification, Official Notification, Apply Online Form Link & Other Relevant Details for Icon Clinical Research Recruitment 2021 are provided below. Interested and eliible candidates can submit application along with resume.
Icon Clinical Research Hiring Life Science, healthcare, engineering Graduates with 03+ Years of Experience for Sr Regulatory Affairs Specialist Position.Complete Details for the Sr Regulatory Affairs Specialist as follows..
Important Details :
- Location :Ireland, UK or Europe Remote
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application:23/01/2023
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
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Job Description/Skills Required
- We are looking for passionate, resilient, and inspiring individuals to join our team. As the Senior Regulatory Affairs Specialist, you will contribute to drug development, as part of the Strategic Regulatory Services (SRS) Regulatory Affairs team through provision of regulatory guidance and operational support to early drug development, agency interactions, clinical trial applications, marketing application and post approval activities.
- As member of the Regulatory Affairs team, you will contribute to at least one of the following activities, working under established procedures and supported by Regulatory Managers/Directorsbut with the ability to work independently for routine activities and submissions :
Preparation, compilation and submission of routine Regulatory submissions e.g. CTA /IND, Variations / lifecycle submissions, orphan designation or PIP
Contribute to more complex projects (early development, MAA/NDA, Post Marketing) contributing to (for example) review and compilation of documents for Scientific advice/variations/MAA, document product label review, translation requirements, fee requirements and payments, submission planning
- Support Regulatory Intelligence
Peer review, QA and/or checking, as appropriate, of documents prepared by other professionals within SRS
Communicate /liaise with clients, regulatory agencies / competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required
Provide support to more senior team members on complex projects
Undertake all required tasks requested to meet departmental and project goals, as appropriate
Participate in regulatory and/or clinical trial project teams as required.
Responsible for timely and accurate completion of assigned projects and for timely identification of issues including the need for change orders.