Senior Specialist, Regulatory Affairs

Everett, WA, USA ● Overland Park, KS, USA ● Virtual Req #1121
Thursday, October 22, 2020

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

Qualifications:

  • Bachelor's degree in Life Sciences (certification/training in regulatory affairs, asset)
  • 5-7 years’ related experience, in the regulatory field preferred
  • Good knowledge of the FDA (required) and Health Canada (desired) standards and guidelines
  • Knowledge of regulatory affairs CMC, pharmaceutical manufacturing and analytical chemistry  
  • Experience of filing and managing regulatory submissions, including electronic submission in eCTD formats
  • Leadership skills
  • Strong interpersonal skills
  • Good verbal and written communication skills
  • Professional attitude
  • Attention to detail and accuracy
  • Ability to work with a multi-disciplinary team of professionals
  • Understanding of clinical research, drug development process, and applicable regulatory guidelines
  • Good computer skills (Microsoft Word, Excel, and Power Point)

Other details

  • Job Family Valide Positions
  • Pay Type Salary
  • Required Education Bachelor’s Degree
  • Job Start Date Monday, October 26, 2020
  • Everett, WA, USA
  • Overland Park, KS, USA
  • Virtual