Regulatory Affairs Specialist in Biologics
6 days ago
Parexel Seeks Experienced Regulatory Affairs Professional
Job Summary
We are seeking a highly skilled and experienced Senior Regulatory Affairs Associate-Biologics to join our team. As a key member of our regulatory affairs team, you will be responsible for handling pre and post-approval life cycle management of drug products, including biologics, in various markets.
Key Responsibilities
- Contribute to the preparation and delivery of regulatory maintenance submissions from a global and/or regional perspective.
- Working knowledge of EU/US regulatory procedures, including post-approval requirements, and knowledge of ROW markets regulatory legislations would be an added advantage.
- Experience in handling CMC-related health authority queries and regulatory review of documentation to ensure compliance with regulatory requirements.
- Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions.
- Liaise closely with cross-functional members with aligned product responsibilities.
- Execute and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated stakeholders.
Requirements
- Around 4-8 years of relevant experience in handling pre and post-approval life cycle management of drug products (small molecules as well as biologics) in various markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures.
- Working knowledge of EU/US regulatory procedures, including post-approval requirements.
We Offer
A supportive and collaborative work environment, opportunities for professional growth and development, and a competitive compensation package.
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