Job Description

Everett, WA, USA, Overland Park, KS, USA, Harleysville, PA, USA, or Remote/Virtual – Virtual Req #1121

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.


• Regulatory Affairs Strategic Support
o Provide regulatory assessment and principal focus will be to ensure US-FDA regulatory intelligence is current.
o Support lead regulatory opportunity feasibility initiatives at the management level
o Provides regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements
o 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
o 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
o Provide strategic guidance on regulatory requirements on sponsor’s product development programs when prompted through the regulatory design process or through the sales process
o Ensures all groups are current with present and upcoming US-FDA and international guidelines and regulations pertinent to the research services provided by Altasciences
o 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
o Provides regulatory support for drugs, biological products, medical devices, 505b2 program, IND requirements
o Support the organization in drug development files to be submitted to the regulatory bodies (ex.: pre¬IND, IND)
o Provide regulatory support in scientific meetings/exhibitions or business meetings
• Regulatory Submissions
o Overseeing the preparation, review and submission of INDs to FDA Centers (CDER, CBER, CDRH)
o 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
o Analyses the information provided by the sponsor and prepares a complete file showing the relevant information to the regulatory body
o Oversight and/or preparation of all responses to all FDA requests, clinical hold, etc.
o Oversight for the Maintenance of submission (IND Annual Report, Amendments, etc.)
• Line management:
o Ensures quality and on-time performance for deliverables of team members assisting in the IND preparation; ensures internal and client milestones/expectations are met
o Oversees team members assisting in US-FDA regulatory submissions to ensure they are conducted in compliance with SOPs, relevant regulations, and goals of submission
o Participates in the development of unit SOPs

Job Requirements


• 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: December 2020

Altasciences is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race,
color, religion, sex, sexual orientation, gender identity, or national origin, and protected veteran status, or disability status.

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