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Manager/Senior Manager, Regulatory Affairs

Ultragenyx Pharmaceutical Inc.

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Location: Novato, CA Posted Date: 5/3/2013 Position Type: Full time Job Code: MRG REG - 20130503 Required Education: High school or equivalent Areas of Expertise Desired: Regulatory Affairs

Description

The Manager, Regulatory Affairs will be responsible for managing all regulatory aspects (nonclinical, clinical, CMC) of a substrate replacement therapy program with multiple indications. The responsibilities include working closely with functional areas and project teams to support product development and approval.   The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development. Strong communication and management skills are required. The position level is dependent on experience and qualifications.

Responsibilities:

•   Create and maintain regulatory timelines and track deliverables to timelines to ensure regulatory submission timelines are met.
•   Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on development program.
•   Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks.
•   Develop and/or review regulatory documents to ensure that all submissions are of high quality.
•   Provide critical review of documents (SOPs, protocols, and reports) related to clinical, nonclinical or manufacturing, as necessary.
•   Interface with functional areas (CMC, Nonclinical, Clinical, Commercial) to identify and obtain information required for regulatory submissions.
•   Prepare/coordinate/file/manage IND/CTAs, annual reports, and information amendments in multiple countries for multiple protocols.
•   Prepare/coordinate/file/manage regulatory applications (IND/CTA, NDA/BLA/MAA).
•   Interface with global regulatory authorities and consultants.
•   Coordinate, prepare for and conduct Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages.
•   Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development,  as well as knowledge of therapeutic area.

Requirements

•   BA/BS degree in life sciences or experience in drug development that allows for sufficient knowledge in this area.
•   Strong scientific background with at least five years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
•   Prior experience with product development in a project management role with relevance to early phase non-clinical, clinical and/or CMC drug development.
•   Excellent attention to detail with solid coordinating, task planning and time management skills.
•   Outstanding verbal, written and interpersonal communication skills.
•   Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability.
•   Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies.
•   Thorough understanding of global drug development regulations and guidelines.
•   Proven ability to successfully manage major submissions and critical projects to deadlines.
•   Proven ability to successfully interact with regulatory authorities.
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