Senior Specialist, Regulatory Affairs is responsible for managing IND acceptability with US-FDA principal focus will be CDER and CBER submission development. The position provides regulatory support to the other company divisions and acts as a regulatory consultant with the clients who drug development strategy is to gain drug approval by the US-FDA. The incumbent may assist Sr. Director in line management as required.
Responsibilities:
- Regulatory Affairs Strategic Support
- Provide regulatory assessment and principal focus will be to ensure US-FDA regulatory intelligence is current.
- Support lead regulatory opportunity feasibility initiatives at the management level
- Provides regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements
- May participate in the preparation of drug development files to be submitted to the regulatory bodies (ex.: pre-IND, IND). Should have a basic knowledge of Health Canada CTA process
- Interact cross-functionally with various personnel to identify and obtain relevant documentation and data on safety, efficacy, performance, adverse events and risk/benefit profile of a drug development program and support our regulatory design initiative
- Provide strategic guidance on regulatory requirements on sponsor’s product development programs when prompted through the regulatory design process or through the sales process
- Ensures all groups are current with present and upcoming US-FDA and international guidelines and regulations pertinent to the research services provided by Altasciences
- Ensures each site manages and coordinates US-FDA regulatory submission deficiencies for their prompt resolution, and monitor their receipt to identify and lead improvement opportunities
- Provides regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements
- Support the organization in drug development files to be submitted to the regulatory bodies (ex.: pre¬IND, IND)
- Provide regulatory support in scientific meetings/exhibitions or business meetings
- Regulatory Submissions
- Overseeing the preparation, review and submission of INDs to FDA Centers (CDER, CBER, CDRH)
- Main company contact and regulatory liaison with FDA; communicates with FDA to ensure the feasibility and filling requirements of IND applications CMC, non-clinical studies & clinic trials submitted to gain IND approval
- Analyses the information provided by the sponsor and prepares a complete file showing the relevant information to the regulatory body
- Oversight and/or preparation of all responses to all FDA requests, clinical hold, etc.
- Oversight for the Maintenance of submission (IND Annual Report, Amendments, etc.)
- Line management:
- Ensures quality and on-time performance for deliverables of team members assisting in the IND preparation; ensures internal and client milestones/expectations are met
- Oversees team members assisting in US-FDA regulatory submissions to ensure they are conducted in compliance with SOPs, relevant regulations, and goals of submission
- Participates in the development of unit SOPs
