Regulatory Affairs Specialist
1 month ago
At Parexel, we're driven by a shared passion for delivering exceptional results. When our values align, there's no limit to what we can achieve.
Key Responsibilities:- Lead and/or contribute to the planning, preparation, and delivery of regulatory maintenance submissions from a global and/or regional perspective.
- Develop and execute submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Prepare, review, and submit safety variations to Health Authorities and perform post-approval CMC-related updates.
- Collaborate with regulatory teams to ensure compliance with regional trends and regulatory frameworks.
- Develop and maintain expertise in regulatory procedures, including post-approval requirements and global pharmaceutical legislation.
- Provide guidance on regulatory information management systems, such as Veeva Vault.
- 8+ years' experience in handling life cycle management of approved drug products.
- Good understanding of regulatory frameworks, including regional trends, for various types of applications and procedures.
- Working knowledge of EU/US regulatory procedures, including post-approval requirements.
- Experience in handling CMC-related health authority queries.
- Strong communication skills and ability to work independently.
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