Parexel Released Job Openings On 30/07/2022.PAREXEL International Corporation is a leading global biopharmaceutical services organization, providing a broad range of expertise-based contract research, consulting, medical communications, and technology solutions and services to the worldwide pharmaceutical, biotechnology and medical device industries.
Parexel Recruiting Bachelors/Masters in Pharmacy OR Bachelors/ Masters in any of Life Sciences Graduates with 01+ years experience for Regulatory affairs associate Position.Complete Details for the Regulatory affairs associate as follows.
Important Details :
- Location : Remote
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: NA
- Opening date for online Application:30/07/2022
- 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
Job Description/Skills Required
Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions as well as knowledge of global pharmaceutical legislation and guidance specifically linked to regulatory CMC aspects in the ICH countries . Experience with ROW countries would be a plus.
Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.
Liaise closely with cross-functional members with aligned product responsibilities.
Develop, execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
To prepare, review and submit safety variations to Health Authorities and also perform post Approval CMC related updates (where applicable)
Ensure that the Regulatory Information Management system is maintained and updated for all activities under role responsibility, including review of documents
Prior working experience in Regulatory Information Management Systems like Veeva Vault would be desirable