Vice President, Regulatory Affairs - Palo Alto, CA | Biospace
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Vice President, Regulatory Affairs

Eiger BioPharmaceuticals, Inc

Location:
Palo Alto, CA
Posted Date:
7/12/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Regulatory Affairs,

Job Description

The Role:
The Vice President of Regulatory Affairs will manage and, as needed, build a premier regulatory group that provides strategic leadership for regulatory strategy, regulatory operations, agency interactions, and submissions, both domestically and globally. The candidate will work cross-functionally to develop and implement regulatory strategy and provide leadership of all regulatory submissions including briefing documents, INDs, NDAs, BLAs and supplemental applications. Additional responsibilities include: regulatory compliance, regulatory advice and counseling, review of external communications, and assessing the landscape to assess regulatory risks and pathways for expedited development timelines. An integral part of this role is fostering strong relationships with FDA and international regulatory authorities.  

The ideal candidate will possess the following abilities or characteristics:
•   An understanding of how to leverage the resources of an emerging biopharma company to successfully manage multiple priorities across a diverse therapeutic pipeline.
•   Provide regulatory guidance that expedites the review process for drugs with an orphan designation.
•   Convert strategy to regulatory execution. Provide leadership of internal resources and external partners to ensure successful regulatory execution.
•   In alignment with Company’s global regulatory strategies, develop and lead the implementation of regulatory strategies throughout all stages of clinical and commercial development.
•   Design regulatory strategies and build a stage-appropriate team to support business decisions, product applications and claims, from development through product lifecycle management.
•   Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Company products and provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and planning.
•   Facilitate best strategy for clearance/approval of products in rest-of-world regions.
•   Act as primary strategic contact with the FDA and other regulatory agencies to enable execution of company regulatory goals.
•   Develop and design appropriate regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction.
•   Support Pharmacovigilance and Safety functions.
•   Provide guidance to business development regarding critical evaluation of potential product opportunities.
•   Develop and plan regulatory strategies that yield differentiated product labels.
•   Oversee all required ongoing regulatory submissions.
•   Provide regulatory review and approval of external communications in support of clinical trials and marketing of approved products.


Requirements

Education:
BS Degree required; RPh, PharmD, PhD or MD degree preferred.

Experience:
The ideal candidate will possess at least 10 years of experience leading Regulatory Affairs within the pharmaceutical industry including specific leadership and management.  Experience in the review and approval of small and/or large molecules for orphan and/or ultra-orphan diseases is advantageous. Building and running Regulatory Affairs within an emerging biopharma company is also an advantage.

Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and submission activities.

Other Skills and Abilities:  
The Vice President of Regulatory Affairs will have a strong understanding of US and global pharmaceutical drug development and regulatory environment, particularly within the FDA and EMA. Ideally, this executive will have a history of active involvement with highly collaborative partnerships and in/out-licensing business opportunities. The VP of Regulatory Affairs will also possess the ability to assimilate and interpret trends in the US healthcare policy environment that directly affect business decisions in the pharmaceutical/biotech industry.

Candidate must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups. This person will demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards. Candidate will be entrepreneurial, innovative, energetic, hands-on, team-oriented, and customer-focused, with the ability to think strategically as well as execute project details.