Valeant Pharmaceuticals

Regulatory Affairs Director

US-WA-Seattle
Job ID
9168
Pos. Category
R&D
Pos. Type
Full Time

Overview

Dendreon Pharmaceuticals LLC is a healthcare company whose mission is to transform lives through the discovery, development, commercialization and manufacturing of novel personalized immune-therapeutics for cancer.

 

General Summary:
Leads and/or participates on interdisciplinary regulatory teams responsible for defining and implementing regulatory strategy, including plans to submit Marketing Applications globally. Provides regulatory leadership on cross-functional development teams.

Responsibilities

• Provides regulatory leadership on cross-functional development teams.
• Participates in the implementation of rapid critical path strategies.
• Assists with the development of materials for FDA and other Global Health Authorities.
• Assists with the definition of novel approaches to product registration.
• Assesses the impact of additions/changes to regulations and guidelines, and evaluates relevance to company and product interests.
• Contributes to the development of department budget.
• Leads multidisciplinary teams in the authoring of regulatory communications such as regulatory briefing packages, Regulatory/Clinical/Quality reports and documents, Protocols, CSRs, Annual Reports, and INDs /BLAs, etc.
• Provides leadership and advice to achieve goals to meet objectives. Work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect areas managed.
• Responsibilities include providing guidance and advice to senior management to achieve goals for regulatory timelines, strategy, nonclinical and clinical testing; providing regulatory expertise and guidance to company personnel.
• The successful candidate will possess demonstrated experience working with senior management; team leadership qualities, including an ability to lead and motivate experienced professionals; strong verbal, written, and listening communication skills, including presentation/public speaking skills; demonstrated problem-solving, decision-making and negotiating skills, and a proven ability to resolve conflict. Develops materials for and leads key interactions with regulatory authorities. A hands-on approach is vital.
• May be responsible for a functional area and may not have subordinate supervisors, or employees, or may manage highly skilled professional employees.

 

Qualifications

• BS/MS/PhD in a scientific discipline with at least 10 years direct Regulatory experience in biotech or biopharmaceutical industry.
• Prior clinical drug development experience
• Experience with advanced cellular therapy products is highly desired.
• Typically 5 - 7 years leadership experience.
• Knowledge of cGMP/ICH/FDA regulations.

 

Working Conditions and Physical Requirements:
• Some travel required.

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