Regulatory Affairs Expert
1 month ago
Overview
">Parexel seeks a highly skilled Senior Regulatory Affairs Associate-Biologics to join our team. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with global regulatory requirements and maintaining the integrity of our clients' products.
">About the Role
">We are seeking an experienced professional with 4-8 years of relevant experience in handling pre and post approval life cycle management of drug products, including biologics and small molecules, across various markets.
">Your primary responsibilities will include:
">- ">
- Preparing and delivering complex regulatory maintenance submissions, including authoring and coordinating with cross-functional teams to ensure timely and accurate submissions.">
- Providing regulatory impact assessments for change proposals and identifying required documentation for EU submissions.">
- Liaising closely with cross-functional members to ensure aligned product responsibilities and effective communication.">
- Executing and maintaining submission delivery plans and proactively providing status updates to designated stakeholders.">
- Reviewing and submitting safety variations to Health Authorities and performing post Approval CMC related updates.">
Requirements and Qualifications
">To be successful in this role, you will need:
">- ">
- A strong understanding of regulatory frameworks, including regional trends, for various types of applications and procedures.">
- Excellent communication and project management skills, with the ability to guide and mentor team members.">
- Working knowledge of EU/US regulatory procedures, including post approval requirements, and ROW markets regulatory legislations.">
- Experience in handling CMC related health authority queries and preparing documentation for different types of Variation procedures.">
- Familiarity with Regulatory Information Management Systems like Veeva Vault.">
- Ability to work independently and as part of a team, with strong problem-solving skills and attention to detail.">
Benefits
">Parexel offers a competitive salary range of $120,000 - $180,000 per annum, depending on experience, plus benefits and opportunities for career growth and development.
">Location
">This role is based in [insert location], with regular travel to client sites and internal meetings.
">About Parexel
">Parexel is a leading clinical research organization that provides comprehensive solutions for pharmaceutical and biotechnology companies. We are committed to delivering high-quality services that meet the evolving needs of our clients.
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