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。
Regulatory Affairs Consultant (Biologics/Small Molecules)
応募 求人ID R0000035714 ロケーション バンガロール, カルナータカ州 仕事内容- Around 7-10 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.
- Lead and / or contribute to the planning, preparation, authoring and delivery of regulatory maintenance submissions from either a global and/or regional perspective.
- Responsible for managing (Authoring and Review) of biosimilar investigational product submission such as IND & IMPD for USFDA, EMA
- Authoring, review, and submission of BLA/MAA of biosimilar dossiers for US/EU/ROW /India markets.
- Preparation / Review of Regulatory gap analysis and strategy documents (with remediation plans for identified gaps) for submissions like IND, IMPD, DMF, BLA, NDA, and MAA applications.
- Life cycle management (LCM) for approved products. (Annual reports, variations, renewals) for Europe (Type IA/IB/II/IAIN) / US and other ROW markets.
- Evaluation of change controls and deviations and defining regulatory strategy .
- Co-ordination with internal and external stake holders for documentation required for filing. Identify quality and/or timeliness issues with source documents, as early as possible
- Develop up-to-date knowledge about regulatory guideline updates and applies regulatory requirements and their impact on submissions.
- 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.
- Review and submit safety variations to Health Authorities and perform post Approval CMC / labeling related updates.
- 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.
- Artwork management for countries with label in English.
