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Director/Senior Director, Regulatory Affairs

Portola Pharmaceuticals, Inc.

Location:
South San Francisco, CA
Posted Date:
7/3/2014
Position Type:
Full time
Job Code:
Director, Regulatoary Affairs
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Cardiology, Clinical Research, CMC, Project Management, Regulatory Affairs,

Job Description

Portola Pharmaceuticals, Inc. was founded in 2003 and is headquartered in South San Francisco, Calif. We completed an initial public offering in May 2013 and are traded on the Nasdaq Stock Market under the symbol PTLA. We have approximately 80 employees. At Portola, our goal is to build an enduring biopharmaceutical company with compounds from our own research efforts that advance the care of patients in the areas of thrombosis (blood clots), other hematologic disorders and inflammation. Our current development-stage portfolio includes wholly-owned and partnered products. Our two lead programs, betrixaban and andexanet alfa (PRT4445) each address significant unmet medical needs in the area of thrombosis. Our two other product candidates, PRT2070 and PRT2607, are orally available kinase inhibitors with unique pharmacologic properties targeting hematologic (blood) cancers and inflammatory disorders.

Position Summary:
The Director/Sr. Director, Regulatory Affairs will be responsible for global regulatory leadership, management and strategic guidance for all regulatory aspects (nonclinical, clinical, CMC) of one to two development stage programs. The responsibilities of this position include defining, implementing and delivering the global regulatory strategy for assigned programs. The individual must possess a thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development and be able to provide guidance in interpreting these rules, regulations, and guidelines. Strong leadership, communication (written and verbal), and management skills are required with a hands-on, can-do attitude.

Essential/Primary Duties, Functions and Responsibilities:
•   Develop and implement U.S. and ex-U.S. regulatory strategies and act as a regulatory lead to ensure that all activities are conducted in compliance with relevant laws, regulations, and guidance including with manufacturing, research, clinical, and quality assurance
•   Act as the primary contact for regulatory licensing matters
•   Review labeling and promotional materials throughout the product lifecycle and communicate labeling changes to all stakeholders. This position will interact cross-functionally with members of commercial, legal, safety, clinical, manufacturing, quality, medical, and others
•   Plan, coordinate and prepare documents that are submitted to US and international regulatory authorities in support of INDs, BLAs, DMFs CTAs, NDAs and necessary amendments, safety reports, and annual updates
•   Ensure that regulatory expectations are clear to all internal and external stakeholders (including partners, CROs, consultants and contractors) in order to execute program objectives in compliance with applicable regulations
•   Represent the Company externally in scientific, financial and business development communities, and in meetings with regulatory agencies serve as a credible, influential, respected corporate spokesperson during all interactions with regulators and regulatory agencies
•   Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals
•   Continue positive communications and rigorous interaction with the FDA and other regulatory agencies and ensure activities meet all relevant requirements & guidelines
•   Identify potential compliance issues and work with respective functions in developing corrective action plans to ensure compliance is achieved

Requirements

•   BS, MSc, or Ph.D. degree in the life sciences with a minimum of 15+ years in drug development in the pharmaceutical/biotechnology industry in the regulatory function
•   Thorough knowledge of global rules, regulations, and guidances governing drugs and biologics in all phases of development
•   Experience with planning and filing license applications (NDA, BLA, MAA); Experience with electronic submissions is desired
•   Must have experience filing a minimum of one license application
•   Working knowledge of FDA regulations is required as well as experience supporting global clinical studies
•   Experienced self-motivated individual with a record of achievement as a result of past initiatives in submitting successful IND(s) to NDA(s)
•   Regulatory experience in the review of labeling and promotional material
•   Willingness to handle day-to-day functions while still providing the high-level strategic guidance
•   Open, available, transparent communicator, able to develop a culture of teamwork and collaboration
•   Able to develop and maintain excellent working relationships with global health authorities
•   Experience working with project teams and will be well versed in regulatory terminology with the ability to communicate with experienced regulators in the various governmental agencies
•   Must possess strong leadership, presentation and influence skills
•   Must possess excellent written and verbal skills (articulate and persuasive)
•   Able to advance group goals to meet company objectives
•   Able to provide expertise in shaping company direction

Additional Information:
•   Our company overview and history:  http://www.portola.com/Company-Overview
•   Please include a cover letter that highlights your qualifications and matches our requirements and send resumes to careers@portola.com
•   Recruiters:  Please click this link for more information:  http://www.portola.com/Recruiters-and-Vendors  

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