Senior Manager Regulatory Affairs

April 30

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Beyond the science | using technology-enabled services to accelerate decision making and drive efficiency gains

Regulatory Affairs • Pharmacovigilance • Regulatory Operations • Pharmaceutical Quality • Audit / Inspection Preparation

1001 - 5000

Description

• Act as a key regulatory affairs consultant, providing expertise and innovative solutions to clients and internal teams on US and Canadian regulatory strategy, process, filing, best practices, etc. for a broad range of product types and indications. • Develop and drive execution of short and long-term regulatory strategies and translate into tactical operational plans for execution. • Lead cross-functional submission teams and communicate regulatory requirements to ensure optimal execution of the regulatory strategy. • Ensure timely preparation, review, and submission of documents to regulatory authorities, and ensure compliance with applicable regulatory requirements. • Coordinate, prioritize and track regulatory activities and submissions associated with clients’ research, development, and post-marketing activities for a variety of therapeutic areas.

Requirements

• 5+ years of experience and broad knowledge in the field of Regulatory Affairs, especially generics, prescription drugs and biologics (food, dietary supplements and veterinary drugs experience is a plus) • Good understanding of the North American regulatory landscape, especially Health Authority regulations, guidance documents, processes, and timelines • Strong critical thinking and leadership skills • Results focused approach and strong sense of responsibility • Strong work ethic and proven adaptability to meet client needs • Structured, analytical, systematic, focused, and able to deliver high-quality work • Strong command of the English language and excellent written, verbal and presentation communication skills

Benefits

• This is a remote opportunity • Travel up to 5%