Regulatory Affairs Consultant

2 weeks ago

Bengaluru India Parexel Full time

Job Description - 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.

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