パレクセルでの仕事
パレクセルは、臨床開発の上流から下流までのそれぞれの専門領域で、国内外の多くのお客様に高度なソリューションを提供するプロフェッショナル集団です。 パレクセルは、新しい薬や治療法を、それらを必要としている人々にいち早く届けることを目指し、日々の業務に取り組んでいます。
Senior Regulatory Affairs Associate (Biologics/Small Molecules)
応募 求人ID R0000035715 ロケーション バンガロール, カルナータカ州 仕事内容- Around 4-6 years of relevant experience in handling life cycle management of approved drug products (small molecules as well as biologicals including Vaccines, monoclonal antibodies) in various markets.
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures
- Contribute to 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.
- Working knowledge of EU/US regulatory procedures including post approval requirements. Knowledge of ROW markets regulatory legislations would be an added advantage
- Experience in handling CMC related health authority queries
- 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.
- Preparation and review of Marketing Authorization Applications & Variations for various types of medicinal products (orals & parenteral) for filing in EU through different types of procedures (DCP/MRP/National Procedures).
- Preparation of documentation for different types of Variation procedures like Super grouping,
- Grouping and Work-sharing to the Marketing Authorizations.
- Regulatory review of DMFs, batch records, specifications, and stability data to ensure their compliance with the regulatory requirements.
- Providing regulatory impact assessment for change proposals and identification of required documentation for EU submissions and other regulated markets.
- 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.
- To prepare, review and submit safety variations to Health Authorities and perform post Approval CMC related updates.
- Working experience in Regulatory Information Management Systems like Veeva Vault.
- Strong communications skills and ability to guide and mentor team members.
- Ability to work independently.
- Authoring content of the label (EU, Canada, AU/NZ & US) based on Company Core Data Sheet (CCDS) / PRAC / CMDH recommendations.
- Familiarity with EU Guidelines for QRD / Excipients.
