Exciting news for B. Pharma and M. Pharma graduates! Parexel, a renowned leader in the healthcare and life sciences industry, is seeking talented individuals to join as Regulatory Affairs Associate. Take the next step in your career with this esteemed opportunity. Apply now and embark on a rewarding journey with Parexel, where innovation meets excellence in regulatory affairs.
Job Title: Regulatory Affair Associate
Qualification: B. Pharma/ M. Pharma
Experience: 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts.
Salary: Competitive
Job Roles and Responsibilities
- To understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including:
1.Submission delivery strategy
2. Review of documents
3. Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product. - 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.
- Authoring the dossier sections based on the changes to approved MAA
- Knowledge of change evaluation according to country guidelines
- Experience in managing lifecycle activities in the EU markets would be preferrable
- Knowledge of CTD guidelines
Job Location: Hyderabad, India
Job ID: R0000021383
Category: Regulatory / Consulting
Date Posted: 04/18/2024
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