Regulatory Affairs Consultant (Biologics/Small Molecules)

India

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.