Regulatory Affairs Consultant (Biologics / Small Molecules)

When our values align, there's no limit to what we can achieve.

• 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.